#fda guidance on remote monitoring

[ccrpsorg]

Decentralized Clinical Trials and Contract Research Organizations in 2023

Decentralized Clinical Trials for the CRO

Decentralized clinical trials (DCTs) are a relatively new concept in the world of clinical research, but they are quickly becoming more popular. In 2023, DCTs are expected to become even more widely used as the technology and infrastructure needed to support them continues to develop.

A decentralized clinical trial is one that is centered around patient needs and improves the patient experience by allowing them to participate from their own homes or local healthcare providers. This type of trial eliminates the need for patients to physically access hospital-based trial sites, which can be difficult for some people due to distance or other factors. It also allows for greater flexibility in terms of scheduling and data collection, as well as improved accuracy of results due to fewer potential sources of error.

In addition to these guidelines from the FDA, there are several ethical considerations that must be taken into account when conducting a decentralized clinical trial. These include ensuring patient privacy and confidentiality, providing informed consent forms that clearly explain the risks associated with participating in a DCT, and ensuring that all participants have access to appropriate medical care if needed during the course of the study.

How CROS can Implement DCTs

Contract research organizations (CROs) can implement decentralized clinical trials by modifying their protocol to incorporate remote data collection, patient-centric protocols, and virtual engagement between trial participants and CRO personnel. Remote data collection allows for the capture of participant-generated data outside of a traditional clinical setting via digital devices. Patient-centric protocols allow for a more personal approach to clinical trials by allowing patients to participate in activities such as self-reporting on symptom severity, digitally submitting medical images and lab results, and engaging with physicians from the comfort of their own home. Virtual engagement between trial participants and CRO personnel can be facilitated through secure video conferencing tools that enable real-time interactions.

Further modifications to the CRO protocols could also include integrating artificial intelligence technology into the trial process such as automated monitoring of patient behavior, prioritizations of interventions based on individual risk profiles, and remote health guidance by virtual nurses or other healthcare professionals. Mobile applications could also be used to remind participants about upcoming appointments or events related to the study as well as remind them about taking medication or completing questionnaires. Incorporating these types of technologies would ensure that decentralized clinical trials are conducted efficiently while providing participants with an enhanced user experience throughout every step of the trial process.

Five Steps to Implementing Decentralized Clinical Trials

1.Educate Project Managers: Contract research organizations (CROs) should ensure that their project managers are educated about the benefits of decentralized clinical trials and how to go about implementing them. This could include learning about the technology, regulations, data privacy, and other important elements related to this type of trial design.

2. Establish Data Security Measures: Before conducting a decentralized clinical trial, CROs should have strong data security measures in place to protect participants’ information and ensure that it is secure throughout the study duration. This includes accessing participant data only with permission and using encryption protocols when transmitting or storing any sensitive information.

3.Evaluate eClinical Platforms: A key part of implementing decentralized clinical trials is choosing the right eClinical platform for your study design. CROs should evaluate the various eClinical platforms available to them and select one that meets their needs for a successful trial, such as being user friendly for participants, having features such as remote monitoring capabilities, offering robust reporting capabilities, and providing easy access to data from multiple sites.

4.Utilize Mobile Technologies: To make a decentralized clinical trial successful, leveraging mobile technologies can be extremely helpful for CROs to communicate with volunteers remotely, manage participant engagement in real-time, collect patient-reported outcomes quickly and accurately from anywhere, track compliance with protocols on site visits or assessments done remotely, etc., reducing the need for face-to-face visits whenever possible.

5. Create Protocols: Having clear protocols in place is essential if a CRO wants to successfully implement decentralized clinical trials as they help ensure consistency across different sites by setting expectations around communication between sites and central teams; supervision of staff; quality control procedures; safety reporting; use of investigational drugs; collection of patient data; follow up on withdrawals or lost patients; etc., throughout the duration of the trial

How do DCTs Work?

Decentralized clinical trials offer a variety of benefits to CROs, such as reduced costs associated with traditional on-site trials, improved patient recruitment, faster data collection and analysis, and greater efficiency.

Decentralized clinical trials (DCTs) offer a promising new model for contract research organizations (CROs). By leveraging decentralized technologies such as blockchain and distributed ledger technology, DCTs provide a secure, efficient, and cost-effective alternative to traditional CRO models.

The key advantages of DCTs for CROs include enhanced security and data integrity, improved consent management, faster and more secure patient recruitment, and greater visibility into the trial process. With DCTs, CROs can leverage existing research infrastructure while streamlining processes such as data management and quality control.

To further explore the potential of DCTs, it's helpful to look at some recent developments in the industry. In 2018, Decentralized Clinical Trials LLC partnered with Johnson & Johnson to create JLABS@TMCx to develop innovative digital health solutions for clinical trials. This collaboration unveiled two major projects that leverage decentralized technologies: Project Catalyst and Project Ovenbird.

Project Catalyst seeks to develop a system of protocols that will allow researchers to securely exchange information in real-time. The project is currently focused on developing decentralized application (dApp) versions of standard protocols and applications used in clinical trials. Meanwhile, Project Ovenbird seeks to create an enterprise-grade distributed data platform that will enable researchers to collect structured data from decentralized sources while maintaining privacy standards comparable to those set by HIPAA.

In addition to these projects with J&J, Decentralized Clinical Trials LLC has also partnered with Microsoft Corporation on a pilot program called "Verified Credentials." This program leverages blockchain technology to ensure accurate identity verification during patient recruitment processes for clinical trials.

For CROs interested in exploring DCTs further, there are several resources available online that can help provide a better understanding of their benefits, applications, and potential challenges. The National Institutes of Health recently launched the Decentralized Clinical Trials Hub (DCThub), which provides educational materials about DCTs for research professionals. Additionally, several companies offer products tailored specifically for DCTs such as TrialX from OptumIQ or Oneyield from Castor EDC Solutions Ltd., both of which are designed to support decentralized clinical trial design and implementation workflows.

Types of Remote Monitoring in DCTs

Decentralized clinical trials are conducted using remote monitoring technology to capture data from patients rather than requiring them to come into a physical research site. This allows for more flexible trial designs that can be tailored to specific patient populations and geographic locations. In addition, patients can more easily participate in a trial without having to travel or take time off from their daily lives. For example, virtual visits through telemedicine can be used for initial screening and assessments, reducing the number of visits required at an on-site research facility.

Data collected from decentralized clinical trials is often more accurate than what is typically collected in traditional on-site trials due to the use of continuous wearables, mobile devices and other innovative digital technologies that provide real-time monitoring of health parameters such as blood pressure or glucose levels. This increases the quality and granularity of information available to researchers while decreasing the amount of labor required for data collection. Additionally, electronic health records (EHRs) can be integrated with decentralized trial platforms allowing for rich longitudinal datasets that enable deeper insights into patient outcomes over time.

One example of a decentralized clinical trial is the use of telemedicine to support remote monitoring. This could involve providing video conferencing for patient-physician visits and using smartphones for tracking vital signs. In addition, telemedicine can enable doctors to monitor patients with chronic conditions remotely, by collecting medical data from sensors that have been placed on the patient’s body. This type of monitoring allows doctors to keep track of changes in health parameters without requiring an in-person visit, significantly reducing both costs and risks associated with traveling for treatment.

Another example is direct-to-patient (DTP) trials, in which medication is shipped directly to a patient's home instead of them having to travel to a clinic. In this case, study coordinators can monitor the progress remotely via phone calls or text messages while also providing support when needed. This approach has enabled researchers to conduct studies involving large numbers of participants located around the world who would otherwise not have been able to participate due to geographic distance or lack of transportation resources.

Finally, wearable devices are also being used increasingly in decentralized clinical trials as they allow researchers to collect more accurate data about activity levels and other health metrics over long periods of time without needing frequent interventions from healthcare personnel. It is possible for these devices to be connected directly with electronic data capture systems so that the collected information can be analyzed quickly and accurately by researchers.

Larger Patient Engagement

The decentralization of clinical research also opens up new opportunities for CROs to reach larger populations by enabling simultaneous studies across multiple sites around the world and removing many logistical barriers related to travel or geographical distance between participants and study sites. Additionally, leveraging social media platforms for recruiting further expands access potential outside of traditional recruitment networks and offers ways to engage with potential participants more directly than before.

Decentralized clinical trials, also called virtual studies or remote research, have the potential to revolutionize the way clinical studies are conducted. A decentralized clinical trial is a type of clinical study where participants are distributed across geographical and other boundaries, allowing them to participate from their own homes or from one of many remote sites.

To explore further options regarding DCTs and related technologies, interested parties may consult companies such as Medidata Solutions (www.medidatasolutionsinc.com), IMS Health (www.imshealth.com), HRA Pharma (www.hrapharma) or IQVIA (www.iqvia). These firms specialize in providing comprehensive services related to DCT implementation, ranging from development and customization of software solutions through full project management services that cover all aspects of a clinical trial operation from start-up through completion – including training protocols for implementing these new technologies at each site visited during study duration and beyond..

Overall, decentralized clinical trials represent a significant opportunity for CROs looking to move away from costly on-site studies in favor of more cost effective approaches that offer equally robust data sets but require fewer resources from both researchers and participants alike. As technology continues to advance so too will our collective ability to take advantage of decentralized trial designs for bigger impact studies without sacrificing quality or rigor.

Decentralized clinical trials offer many advantages over traditional site-based studies. They provide greater convenience for patients while still maintaining high levels of safety and efficacy standards. As technology continues to advance in 2023, we can expect even more opportunities for DCTs to become available.

More Examples on Decentralized Clinical Trials:

In the past decade, the advent of blockchain and other technologies have made it possible for clinical trials to be conducted in a decentralized manner. Here are five examples of decentralized clinical trials currently taking place across the world.

1. Mediledger Clinical Trial Supply Chain: This trial is being managed by MediLedger, a healthcare-focused blockchain consortium. The goal of this trial is to use blockchain technology to streamline and secure the global movement and tracking of drugs within the supply chain. The solution will enable parties to share data about patient safety, drug expiration dates, and more in real-time – all while remaining compliant with regulatory standards.

2. CardiLynx Smart Phone ECG Readings: This study is being conducted by CardiLynx, a healthcare technology company that specializes in mobile health applications that measure electrocardiograms (ECGs). The aim of this trial is to use an app on a smartphone to accurately detect heart arrhythmias in patients over time, as well as identify early symptoms and risk factors associated with cardiovascular diseases like stroke and heart attack.

3. Cogstate Cognitive Testing Trial: This study is sponsored by Cogstate, an AI-powered cognitive assessment platform that uses computer games to measure cognitive performance across multiple disciplines such as memory, attention and executive functioning. The purpose of this trial is to evaluate how well Cogstate’s technology can accurately detect changes in cognition over time in various patient populations and disease states.

4. Takeda Whole Genome Sequencing Study: This research project is sponsored by Takeda Pharmaceuticals, one of the world’s largest pharmaceutical companies. In this project, researchers are using whole genome sequencing technology to increase our knowledge about genetic mutations related to certain diseases such as hemoglobinopathies or rare blood disorders. They are also trying to identify new treatment options based on these mutations that could help improve patient outcomes overall.

5. Verily Life Sciences Patient Health Monitoring Project: This project involves Verily Life Sciences working with healthcare providers, payers and employers on an initiative called “Project Baseline” which uses wearables and other devices such as Fitbits or Apple watches to monitor patients’ health data in real-time while they go about their daily lives outside of a clinical setting. Through this project, Verily aims to understand how different lifestyle behaviors can influence health outcomes; enhance patient engagement; reduce healthcare costs; and ultimately improve population health management globally

6. GlaxoSmithKline’s digital platform trial: GlaxoSmithKline developed an innovative digital platform to conduct a clinical trial of its new asthma drug, mepolizumab, in the United States. The trial involved recruiting participants through a web-based interface, using secure electronic data capture (EDC) tools to collect and store data in real time, and utilizing mobile devices for remote patient monitoring. This decentralized clinical trial was able to reduce the traditional costs associated with running a large-scale clinical trial because it eliminated many of the steps required for enrollment and data collection. Additionally, it enabled GSK to recruit more geographically diverse participants who would not have been able to take part in a conventional trial setting.

7. Merck's MyEHRConnected study: Merck conducted the MyEHRConnected study, which sought to evaluate the efficacy and safety of its diabetes medication Januvia (sitagliptin). This was an international phase III study that utilized electronic health records (EHRs) from more than 60 sites located throughout Europe, Asia Pacific, Latin America and Canada in order to identify eligible patients with type 2 diabetes. The EHRs enabled Merck to recruit participants quickly without requiring physical visits or extensive paperwork. Furthermore, researchers could securely access patient data stored within the EHR system during the duration of the study for analysis and evaluation purposes—a process that would have been impossible with paper-based records.

8. Sanofi's Telcare Diabetes Trial: Sanofi conducted a revolutionary telephone-based randomized control trial known as the Telcare Diabetes Trial (TDCAT), which aimed to assess the impact of telemedicine on diabetes care management among patients at risk for complications due to uncontrolled blood sugar levels. Patients were randomly divided into two groups—one group received standard care while another group received a combination of traditional care plus remote support provided by nurses through weekly phone calls over a period of six months. Results showed that those participants receiving telemedicine services had significantly better glycemic control than those who did not receive any telemedicine services at all—highlighting one powerful benefit of decentralizing clinical trials using technology such as telephone communication services.

9. Novartis’wearable device clinical trial: Novartis launched an ambitious clinical trial involving 20,000 individuals across nine countries in order to evaluate whether wearable devices such as smart watches can detect early signs of heart failure before medical symptoms appear. The decentralized nature of this study offered numerous advantages over traditional studies in terms of cost savings as well as recruitment speed; enabling Novartis to rapidly reach out potential participants worldwide instead of relying solely on localized recruitment methods used previously by other companies conducting similar trials with much smaller sample sizes due to limited resources or geographic restrictions

10. Eli Lilly & Company's eCOA Study: Eli Lilly & Company recently completed an innovative eCOA (electronic Clinical Outcomes Assessment) study that leveraged mobile applications and internet-connected devices in order to record patient outcomes over longer periods of time compared with traditional studies involving paper forms or periodic clinic visits alone. By using this decentralized approach, Lilly was able to gather more accurate data while reducing costs associated with running conventional trials; making it possible for them to enroll larger numbers of patients in shorter periods than ever before.

11. The IQVIA-sponsored study by the Alzheimer's Prevention Initiative (API). This study was designed to evaluate the effects of an investigational oral form of the drug solanezumab on the cognitive decline associated with early stage Alzheimer's disease. It was a decentralized trial conducted using remote monitoring, which allowed participants and clinical sites to interact online via web-based video visits, digital questionnaires and remote diagnostic testing. The trial collected data from over 800 participants at over 30 clinical sites in 12 countries.

12. A decentralized clinical trial launched by Durect Corporation to assess its investigational drug DUR-928 for the treatment of nonalcoholic steatohepatitis (NASH). The Durect NASH study was conducted across 16 countries and used innovative telemedicine technologies for patient monitoring and data collection. In addition to traditional site visits, remote video visits were performed with patients and caregivers to observe adverse events, review patient-reported outcomes, analyze lab results remotely and monitor compliance with the protocol.

13. The Institute for Qualitative Medicine’s (IQM) pilot study that evaluated an innovative approach to decentralizing clinical trials using mobile health technology (mHealth). The mHealth platform was used to connect participants remotely with healthcare professionals who monitored vital signs such as blood pressure, heart rate, respiratory rate, oxygen saturation level and body temperature using wireless medical devices connected directly to smartphones or computers. In addition, the platform included a chatbot that trained participants on how to use their medical device correctly or send real-time reminders when it was time for follow-up appointments or tests.

14. An analysis conducted by PPD Incorporated comparing decentralized vs centralised clinical trials for a Phase IIb study evaluating an investigational vaccine for malaria prevention in children aged 1–6 years old. They found that decentralizing the trial saved approximately 25% in total resources spent compared to a centralized approach and resulted in shorter recruitment times due to increased convenience for both investigators and participants alike compared with centralised approaches where people had to travel long distances for appointments or procedures.

15. A global Phase IIIa research program sponsored by GSK which evaluated an experimental shingles vaccine involving over 17000 elderly individuals across 11 countries in Europe and Latin America including Argentina, Brazil, Chile, Colombia, Germany Spain France Italy Netherlands Poland Portugal UK..The study incorporated various decentralized models such as virtual/remote clinic visits with self-administered questionnaires through smartphones/tablets; home delivery of intervention product; remote diagnostics; online physician/patient communication through video calls; collection of sample storage through kits sent remotely from local courier companies etc., thus enabling a truly distributed model of conducting clinical trials without relying solely on physical presence at site locations

Want to train your staff to run decentralized clinical trials? Enroll them in our in-depth clinical trial certification courses with hours of lectures focuses on remote monitoring alone.

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[spacinternational]

Coronavirus Positive Patients can use Sargas' Remote Monitoring platform to free up hospital beds and Medical Staff

Sargas International is providing remote monitoring of Coronavirus COVID-19 positive patients via it's Chronic Care Management Cloud Technology that are kept in isolation," said Git Patel, CEO of Sargas Pharmaceutical Adherence and Compliance (SPAC) International. "This will help reduce the burden on hospitals and care providers, while providing safer home care for COVID-19 positive patients." Patient's with smart phones can use Bluetooth Pulse oximeter (which we can provide), blood pressure monitor, and wearables (e.g. Apple watch, fit bit) to automatically log their vitals into our system. Our telehealth physicians can then monitor for O2 saturations approaching less than 92%, make contact with the patients, and direct them to the emergency department as needed. If patient's do not have cell phones, they can enter their data from their device or a case manager can call and get the data to input in the cloud so that our team can monitor. In this war against COVID-19, Sargas is making this platform available to all hospitals, healthcare providers and COVID-19 patients.

 Hospitals and providers can sign up at https://spacinternational.com/sign-up-physician.php

 Coronavirus Positive Patients can sign up at https://spacinternational.com/sign-up-patient.php

 Please select Remote Patient Monitoring from the drop down under services and include your email, address, phone number and physician name to activate.

 "SPAC Chronic Care Management Physician, Patient and Pharmacy Portals® are ONCHIT certified, and all the physiologic data uploaded to our platform comes from FDA approved health monitoring devices as per the latest FDA guidance. CMS started reimbursing for Remote Patient Physiological Monitoring effective January of last year and they have allowed for general supervision starting from January 2020, where Sargas' certified case managers can monitor the patient's vital health data," continued Git Patel.

 About Sargas International:

 Interoperability developed through Sargas Chronic Care Management Cloud® Portals, Drug Adherence®, Medication Therapy Monitoring® (MTM), Sargas mHealth technologies and compassionate clinical call center help achieve the Triple Aim in healthcare by improving patient experience, health and reducing per capita cost of health care. This helps us in making Oncology Care Model (OCM), Chronic Care Management (CCM), Principal Care Management (PCM), Remote Physiological Monitoring (RPM) Transition Care Management (TCM), and Oncology Care First (OCF) Model feasible, scalable and sustainable.

Visit https://spacinternational.com/

[healthcare-domain]

The Future of Fetal Monitoring Market

The coronavirus pandemic has compelled regulatory bodies, such as the FDA, to ease their regulatory norms for fetal monitors to support the uninterrupted care regime of expectant mothers. Relaxations in rules have paved the way for several key players to smoothly launch fetal monitors equipped with tele-ultrasound monitoring, noninvasive features, and portable technologies. For instance, the FDA released its updated April 2020 FDA guidance amid the pandemic, under which Philips successfully launched its fetal monitor, Avalon CL, in the US on June 12, 2020. The FDA’s enforcement policy for noninvasive fetal and maternal monitoring devices aims to increase access to devices that could reduce the need for in-clinic visits and reduce the burden on doctor’s offices and hospitals during the pandemic.

The outbreak of COVID-19 has led to various valuable partnerships among companies, which is anticipated to fuel the market's growth. For instance, in January 2021, Israel-based Nuvo Group (offering a remote pregnancy monitoring platform) entered into a commercial agreement with Axia Women’s Health, an innovative women’s health network. Under the agreement, Axia Women’s Health will be able to prescribe INVU to expectant mothers, which is expected to reduce the risk of exposure during COVID-19.

The fetal monitoring market is expanding with the latest innovative technologies, backed by escalating research and product launches. Fetal monitoring technologies are now being streamlined to provide greater assistance in utero fetal surgeries, consisting of challenging physical fetal access and technological complications. Fetal cardiac assessments have also witnessed progress that supports high-fidelity hemodynamic and continuous physiologic monitoring, thus enabling early diagnosis and treatment.

Computer-Aided Decision Support Systems and Artificial Intelligence (AI) are also utilized in continuous cardiotocography (CTG) or fetal heart rate (FHR) auscultation during labor. The patient’s electronic health records (EHRs) are utilized along with computational methods, machine learning, and deep learning tools.

Research and technological advancements in fetal monitoring systems have increased focus on noninvasive monitoring procedures. Obstetrics has been introduced with noninvasive diagnosis technologies such as Doppler studies, cell-free fetal DNA assessment, electronic fetal monitoring (EFM), and fetal acid-base status.

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Fetal and neonatal assessments are carried out during antepartum via percutaneous umbilical cord blood sampling and during intrapartum with fetal scalp blood sampling immediately after birth. Fetal phonocardiography has been integrated with advanced data acquisition systems and databases. Progressing data analytics, synthetic data generation by advanced mathematical models, and classifications & processing algorithms are under active research & development to increase fetal motoring data processing efficacy.

The key manufacturers in fetal monitoring market are expanding their product lines to include portable and wireless monitoring systems that are accurate, safe, and affordable. The key players in the market are also integrating telecommunication into these devices. For instance, Philips launched the handheld and tele-ultrasound solution, Lumify, in Japan and Avalon CL in the US in 2020.

Similarly, the strategic collaboration between MindChild Medical and Henry Schein Medical expanded the MERIDIAN M110 Fetal Monitoring System's distribution and supply, a noninvasive intrapartum monitor in the US, in 2019.

Based on the method, the market is segmented into invasive and noninvasive. In 2020, the noninvasive accounted for the largest share of this market. Noninvasive methods are widely accepted for their safer method of diagnosing and monitoring the fetus, especially in high-risk pregnancies. The rising approvals of various noninvasive monitoring devices and the incoming advanced technologies drive the growth of this segment.

The major players operating in fetal monitoring market are Cardinal Health, Inc. (US), Koninklijke Philips N.V. (Netherlands), GE Healthcare (US), Siemens Healthineers (Germany), FUJIFILM SonoSite, Inc. (US), Natus Medical Incorporated (US), Huntleigh Healthcare Limited (UK), The Cooper Companies Inc. (US), CONTEC Medical Systems Co., Ltd. (China), EDAN Diagnostics, Inc. (China), Neoventa Medical AB (Sweden), Bionet Co., Ltd. (South Korea), Progetti Srl (Italy), TRISMED Co., Ltd. (Republic of Korea), ShenZhen Luckcome Technology Inc. (China), MedGyn Products, Inc (US), Dixion (Germany), Promed Group Co., Ltd. (Hong Kong), Advanced Instrumentations (US), BRAEL-Medical Equipment (Poland), GPC Medical (India).

[wyndhamclinicsite-blog]

Clinical Trial Budgeting and Technological Impact

The current clinical trial and drug regulatory process have lagged behind advances in scientific research. Regulatory approval is based on the evidence of efficacy and safety gathered from pivotal trials. Most experts agreed that traditional approach to drug development constitute a blunt tool where a more focused experiment could suffice instead of a one-size-fits-all approach which is ineffective and wasteful.

According to studies conducted by New England Journal of medicine, almost nine in ten clinical trials do not meet FDA requirement and thus do not reach the market. Project fails when they do not meet endpoints. Lack of efficacy and complex protocol are the major cause of failure. To reverse this trend, productivity must be directed towards the poor predictive capability of the current experimental model.

Clinic trial plays a major role in drug development and advancement in technologies such as drug positioning, therapeutic target, and drug efficacy prediction are helping researchers and pharmaceutical companies in drug development.

Traditional trials have fixed parameter that is determined in advance and remain constant throughout out the process. One promising approach to modernizing clinical trials and maximizing efficiency is by adaptive trials which allow for certain parameters such as sample size and treatment regimen to be modified or replace on interim results.

The major hurdle is that investment in clinical research is dwindling as government and stakeholders tightened their budgets. As major sponsors revenue stabilize and cost continue to rise, the clinical trial finds itself in a financial squeeze. Pharmaceutical and medical-device companies have been intent on trimming budgets. Lean contract negotiations are the norm these days, no sponsor is walking around with money burning hole in their budget and most are responding to mandate to save cost by requiring CROs to provide unrealistic competitive budgets which are disastrous. With tightened budget, short-sightedness has become the order of the day and as a result, both sponsors and CROs reputation suffered.

Cutting back drastically or unwillingness to adequately fund a project will produce a poor result. This simplistic strategy is unrealistic and unsustainable. It is important to note that focusing solely on short-term strategy will be detrimental in the long-term. If sustainable research climate is created, prosperity will definitely grow.

There has been increasing effort in utilizing technologies to streamline protocol and boost efficacy in clinical research. The use of technology is empowering research professionals by helping them to make a decision based on resulting data. With the aid of technology, organizations are reducing cost and speeding up evaluation process. Technology allows for accrual of data faster and that information can be disseminated in real time. This can lead to a better decision being made on protocol, patient recruitment, and trial sites.

Here is the list of technologies impacting clinical trials today

Risk Based Monitoring (RMB)

Companies use risk based monitoring to target and prioritize resources, identify risks relating to quality, safety of subjects and integrity of clinical trial data. Risk based monitoring (RMB) can incorporate targeted monitoring or triggered monitoring and reduced source document verification (SDV).

Traditionally, source data verification (SDV) were conducted 100% via on-site monitoring, a labor intensive approach. Reduced SDV limits the measure of SDV at the site, study and subject level.

The quest for more key ways to manage clinical trials has distinguished risk based monitoring which attempts to manage resources without compromising on clinical quality. The variables of protocol compliance, data integrity, and patient safety etc. impact how assets are deployed.

The impact of technology in risk based monitoring is profound and currently in markets are clinical trial management systems (CTMS) and remote data capture (RDC) which can support risk based monitoring system. Some systems still support manual entering and reporting of clinical trial data, for this reason, there is a need to setup more robust systems for flagging and alerting data automatically, these alerts can be developed for notifying those who need to act when an issue arises.

According to Medidata, the cost of onsite monitoring is approximated at 28.7% of study budget and project management at 26.47%. In moving to RMB, monitors can spend their time more judiciously and reduce cost.

Electronic Trial Master File

In biopharma industry, every organization involved in clinical trial maintains a trial master file containing several thousand pages of regulatory documents needed for each clinical trial.

Using a paper-based or hybrid trial master file system to manage thousands of clinical documents, processes and tasks can be overwhelming and can cause errors or misread that can ruin clinical trial and put it at risk for noncompliance.

Organizations usually employed an Enterprise Content Management System (ECM) to manage clinical trial regulatory documents. The ECM based eTMF offers automated methods to index, archive, and report on documents and content.

To eliminate paper from a clinical trial study, electronic signing utilizing digital signatures from verified users is being employed. Globally, most countries including the US and many countries in EU are accepting digital signatures in place of wet signatures thereby eliminating the need for scanned documents.

An electronic trial master file (eTMF) offers a robust platform to document management which allows study team members to gain a quick insight necessary to efficiently manage clinical trials and speedup time to market. Electronic document management processes are being adopted at a steady pace as it becomes vital to business productivity, shortened biopharma product development timelines, and cost cutting.

eSource

In 2013, the FDA release its Guidance Document on Electronic Source Data in Clinical Investigations, since then sponsors and study sites have been adopting and employing eSource as a method of recording data in clinical trials.

The definition of electronic source (eSource) is a clear concept -- to capture or process source data electronically, this data exclude the source data that was captured on paper and transcribed into an electronic database. In eSource, the source data element itself must be electronic.

The benefit of eSource is apparent and the FDA endorsed it because it will be useful in: facilitating real-time entering of electronic source data during subject visits, removes the need to duplicate data, allows for accuracy and completeness of data by using electronic prompts for inconsistent and missing data and lessens the chance for transcription errors.

The need to modernize and streamline the way data is collected are evolving, as a result, much of the exploratory done thus far by several pharmaceutical companies have been mostly to build internal competency. In moving forward, it is critical that standards and interoperability within different eSource modalities come together to help create systems that provide accurate data in clinical research.

Using Clinical Data Repository (CDR) to drive optimization

The ability to effective manage, report and analyze data is of paramount importance in clinical trials. The major hurdle is that data from clinical trials are frequently entered by clinicians electronically or manually across multiple channels including EDC, LIMS, CDMS and IVRS and other systems each with unique underpinning needs. This approach causes data to end up in different databases making it complex and time-consuming to leverage and synchronize the data.

There is confusion as to what constitute or defines CDR as distinct from a clinical data warehouse (CDW). CDR can be thought of as consolidated storage and transfer of data for clinical trials including security, workflow, and systems for performing daily task all under one umbrella.

Centralization of the storage and management of data results are the purpose of CDR and to provide a steadfast and reliable infrastructure that supports clinical data analysis and management, facilitate standardization and secure transfer of data, allow for analytics and cross-trial analysis and to leverage data from trials across the pipeline.

In conclusion, progress in here trials and development has been the backdrop to scientific success. While new technology is helping streamline protocol and save cost, the future also requires savvy integration by linking data collected in trials with data generated in the clinical treatment phase, study goals should be aligned with protocol to eliminate activities that do not support endpoints.

[shahramkabiri]

Medical Tryout Scientific and Budgeting Result

The current specialized medical free trial and medicine regulatory plan have lagged guiding developments in research studies. Regulatory endorsement is dependant on the evidence of safeness and efficacy compiled from crucial trials. Many experts concurred that customary strategy for tablet development comprise a blunt instrument the place where a increased concentrated try things out could be sufficient instead of a another-length and width-meets-all process Pearland primary care is wasteful and unbeneficial.

Close to 9 in ten numerous studies tend not to interact with FDA criteria and consequently never achieve the market, consistent with research projects handled by New Great britain Diary of remedies. Plan breaks down while they tend not to satisfy endpoints. Deficit of effectiveness and difficult protocol will be most important factor for breakdown. To invert this movement, production will be guided with the unhealthy predictive ability of the existing experimental model.

Facility demo represents a main job in medication building and advancement in techniques which include substance position, extremely helpful objective, and medication effectiveness forecast are supporting scientists and pharmaceutical people in pharmaceutical building.

Common trial offers have permanently fixed parameter this really is decided before you go and continue to be endless in the course of out of plan. Another appealing system of modernizing numerous studies and increasing effectiveness is as simple as adaptive trials which permit for sure factors like for example trial therapy and dimension strategy that need to be modified or change on interim outcome.

The major hurdle is the fact expense in clinical scientific studies are diminishing as govt and stakeholders tightened their financial budgets. The professional medical free trial detects by itself inside capital capture, as principal sponsors cash flow strengthen and cost continuously climb. Drug and health related-tool merchants seem to have been intent on trimming spending budgets. Slender acquire talks will be tradition at the moment, no sponsor is running around with riches using golf hole throughout their spending budget and quite a few are answering mandate of saving money by demanding CROs to render unlikely highly competitive financial budgets that will be terrible. With tightened spending plan, quite short-sightedness is considered the buy of waking time and therefore, both of these sponsors and CROs good reputation experienced.

Trimming rear significantly or unwillingness to properly fund a task will build a poor end result. This simplified approach is unrealistic and unsustainable. You need to be aware that concentrating only on shorter-expression strategy are likely to be damaging inside a long-term. If maintainable researching climate is crafted, affluence will surely raise.

There has been escalating hard work in making use of technologies to streamline protocol and increase efficiency in medical analysis. Use of expertise is empowering basic research experts by encouraging them to generate a conclusion in accordance with producing data. With the help of expertise, companies are bringing down money and quickening analysis plan. Expertise provides for accrual of data sooner understanding that suggestions may well be disseminated instantly. This might lead to an even better plan actually being prepared on protocol, affected person recruitment, and trial run webpages.

This is actually the variety of systems impacting numerous studies in the marketplace today

Possibility Located Checking (RMB)

Firms use associated risk centered monitoring to target and focus on strategies, recognise negative aspects regarding fine quality, safety and security of credibility and themes of professional medical test statistics. Risks based on observation (RMB) can incorporate targeted supervision or induced overseeing and reduced cause paper confirmation (SDV).

Commonly, root information affirmation (SDV) is handled completely by means of on-site supervision, a effort rigorous procedure. Minimized SDV restrictions the measure of SDV around the analysis, location and area measure.

The quest for increased fundamental different methods to organize numerous studies has identified possibility based mostly overseeing which efforts to regulate supplies with no need of troubling on professional medical fine quality.

The parameters of protocol conformity, details credibility, and tolerant safety and security and so forth .. result how resources are deployed.

The shock of expertise in financial risk based mostly checking is intense and by now in markets are scientific free trial managing devices (CTMS) and remote control data harness (RDC) which often guide potential risk based on observation set up. Some devices yet guidance hands-on reporting and entering of specialized medical trial run material, for this reason, there is a have got to startup increased powerful systems for flagging and alerting material routinely, these notifications may well be produced for informing individuals that are required to action when a major issue happens.

The price tag on on-site observing is approximated at 28.7Per cent of investigation monetary budget and undertaking operations at 26.47%, based upon Medidata. In moving to RMB, monitors can spend their time increased judiciously and minimize money.

Electrical Free trial Excel at Document

In biopharma world, any institution taking part in medical free trial maintains a tryout learn computer file filled with a handful of thousand sites of regulatory files needed for each and every clinical trial period.

Simply using a cardstock-primarily based or hybrid trial offer excel at file set up to deal with a great deal of scientific systems, work and docs may well be overwhelming that will bring on issues or misread that might ruin professional medical test and set it in danger of noncompliance.

Organisations nearly always applied a company Articles Managing Set up (ECM) to manage professional medical trial run regulatory reports. The ECM focused eTMF affords computerized ways tocrawl and archive, and report on article content and forms.

To eradicate report at a specialized medical trial run examine, electrical putting your signature on working with electronic digital signatures from confirmed clients will be hired. Across the globe, most cities such as the US and lots of nations around the world in EU are agreeing to virtual signatures instead of wet signatures therefore excluding the necessity for scanned files.

A digital trial period professional computer file (eTMF) provides sturdy program to paper control enabling survey team members to have a swift understanding essential to competently handle medical tests and speedup time and energy to field. Electric powered page control operations have been followed with a steady stride mainly because it seems integral to opportunity production, reduced biopharma supplement progress timeframes, and cost trimming.

eSource

In 2013, the FDA relieve its Support File on Digital Reference Reports in Specialized medical Investigations, since that time sponsors and learn web sites are now making use of and adopting eSource as the manner of capturing data files in clinical studies.

The definition of computerized root (eSource) is really clean idea -- to trap or plan provider information electronically, this data remove the source data files which has been taken on paper and transcribed into an electronic collection. In eSource, the origin knowledge element per se should be electric.

The advantages of eSource is very clear plus Food and drug administration approved it only because it will be useful in: facilitating true-time entering of computerized resource reports for matter appointments, purges the desire to copy info, allows for completeness and preciseness of data by utilising automated prompts for irregular and skipping material and minimizes the chance for transcription errors.

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COVID-19 Impact on Digital Therapeutic in Healthcare and Pharmaceutical Industry

COVID-19 Impact on Digital Therapeutic in Healthcare and Pharmaceutical Industry

Coronavirus pandemic has generated an unpredictable effect on human daily lives as well as on the global economy. The coronavirus has a knockout effect on healthcare industries too and created a notable effect or burden on the already pinched healthcare systems across the world. As the pandemic increases, day by day the healthcare professional overworked their duties to overcome the pandemic but a continuously rising number of cases cause major problems. Due to this patients are looking towards digital technologies for disease monitoring as well as for treatment.

COVID-19 outbreak has also made healthcare professionals look for alternative methods to traditional systems and processes. This is leading to an expedited adoption of digital therapeutics across the industry both from providers and consumers. During the pandemic, several healthcare systems have divided healthcare requirements into essential and non-essential based on urgency and the overall requirement for care. As the non-essential requirements are given less priority during the pandemic, patients are moving towards the digital therapeutics solutions. This is augmenting the adoption of digital therapeutics apps across a variety of therapeutic areas such as mental health illness, substance used disorders, opioid used disorders, cardiovascular diseases, metabolic diseases, inflammatory diseases among others.

Digital therapeutics are entered or invented a long time back they recognized and appreciated from few years especially in this pandemic time. During this crisis time, digital therapeutics play a vital need in self-monitoring as well as the management of chronic diseases. During the pandemic lockdown, there has been an even increased need for patients to self-manage their condition and react in real-time, while still having their doctor monitor their case remotely. These digital therapeutics defined as the “evidence-based therapeutic interventions”, which is supported by the high quality of programs and software as the main ingredient or key parameter to help or assist the patients in prevention, managing, and treating various conditions. Once again in this pandemic called digital therapeutics, as well as prescription digital therapeutics, has come to rescue the serious as well as the normal population.

These apps are easy to download on smartphones, laptops, and tablets and can be linked with patient's daily life and assist the users in disease prevention and overall health management. The COVID-19 outbreak has increased the reliability of patients on digital apps to take an active and informed role in their healthcare. The digital therapeutics solutions have helped to reconnect patients and doctors. Hence, it can be concluded that digital health tools are proving to be invaluable for patients with chronic disease and medical professionals.

The easy availability of smartphones and the need for alternative ways to take care of present health is a notable opportunity for digital therapeutics apps providers to expand features and usage. Companies are focusing on connectivity improvements and the interoperability of apps in terms of data storage and data transfer to healthcare providers. This level of data collection is also useful for tracking overall population health. Before the availability of this kind of data, health authorities were dependent on tedious population studies that had several limitations. Digital therapeutics can provide real-time population health information through mass data collection. As a result, healthcare authorities across the world are taking initiatives for digital therapeutics. Below chart shows the major regulatory change in digital therapeutics which creates a new opportunity for pharma as well as healthcare  industries.

According to the Akili Interactive “CEO (Eddie Martucci)” “he said providers should see that these walls are broken down, and they want to respond. Moreover, everyone understands that we have this taste of efficiency and rapid ability to serve the patient, and we're seeing it happen in real-time.

According to David Klein, CEO of “Click Therapeutics” digital therapeutics can deliver an effective treatment through a digital screen. He also said various healthcare industries fighting against this kind of good battle and proved that healthcare professionals can provide effective and better treatment through the digital screen without a waste of time. Moreover, he also said the coronavirus pandemic situation created a positive impact or effects on digital therapeutics and gain importance in that the emergency health crisis and yielded a near-perfect environment.

The COVID-19 pandemic has highlighted the value of digital approaches more than ever before that are designed to help health professionals and the public to maintain communication about disease and stay updated with fresh information that will enable better strategic planning. 

The digital health market is flooded with various digital therapeutics applications and consumers have a wide range of options to select one of them according to their needs and demand. But, there may be a significant variation in accuracy and capabilities. Till now, in middle or poor income countries or developing countries the adoption rate of digital health applications is primarily narrow due to the lack of awareness, low demand, and is restricted to providing information only. In the upcoming time as the demand and usage of these apps increasing in the market, multi-functionality is becoming common. In order to enhance, the consumer's experience in managing their health, multi-functionalities for online consultation, sending diagnostic test results to healthcare professionals for analysis, appointment scheduling, medication reminders, and review. These apps are superior in assisting consumers in managing and monitoring their health as compared to the information and education apps.

Moreover, apart from digital therapeutics, prescription digital therapeutics (PDTx) also attains importance in this pandemic time as well as in normal situations. PDTx are prescription based apps that is they can only be used when a doctor or physician may prescribe and these apps are approved by the FDA with high accuracy and efficacy. Most prescription digital therapeutics focus on indications with a strong behavioral component — using the smartphone’s components that were originally designed for communication & entertainment to capture, analyze, and transmit medical interventions.

For instance, Pear Therapeutics, Inc., a Prescription Digital Therapeutic based company releases its PEAR-004 app for Schizophrenia disorder during the coronavirus time. The press release also stated that the U.S. Food & Drug Administration (FDA) issued temporary guidance to increase access to digital health devices for treating psychiatric disorders and reduce potential exposure to COVID-19. But, the company is launching a limited distribution program for its product candidate. As the position of digital therapeutics apps becomes more important in the aftermath of the COVID-19 pandemic, national health authorities are expected to launch rating and licensing platforms for higher efficiency and reduce crowding in the market.

For instance,

·         The National Health Service (NHS) in the U.K. has expanded their publicly funded prescribing platform to include consumer apps which are deemed clinically safe.

The sudden outbreak of COVID-19 has highlighted the importance of population health monitoring systems and the burden on healthcare systems. Digital therapeutics has the potential to meet these requirements.

As the coronavirus pandemic increases the need for physical contact and social distancing also increases. The medical apps play a vital role in decreasing the infection rate of the novel coronavirus. The major healthcare authorities and organizations such as CDC (Centers for Disease Control and Prevention), WHO (World Health Organization), and other regional, country & state-level authorities have advised for the minimal physical contact between the general population as well as healthcare professionals and patients. This is because healthcare professionals work in very close proximity with infected patients they might likely contract the virus or act as a carrier which can be further spread to a healthy patient. With the help of digital therapeutics, patients can share their real data with the doctors & physicians without actually visiting the healthcare units or clinics. This approach will not only reduces the contact between the healthcare professional & health people but also reduces the other common infection that patient gets acquired from the hospitals.

The coronavirus pandemic increases anxiety, mood disorders, depressive disorders, and well-being awareness across the world. In a huge population, the pandemic has created a sense of fear of getting infected by the virus, which ultimately increases the adoption of digital therapeutics among the population through smartphones, tablets and laptops. Digital therapeutic applications, software and complementary wearables medical devices play a critical role in accessing information and getting a sense of protection. They provide correct and accurate feedback on body function including the body temperature, heart rate, blood pressure, and others which will help in tracking individual health.

For instance; Sensyne Health plc introduce CVm-Health app to monitor the coronavirus scenario. This app is only applicable in European countries. CVm-Health is a free of cost, easy to use web-based application that provides a secure way for individuals and families as well as sick people.

CONCLUSION

The pandemic of present and post-COVID-19 healthcare is expected to see a huge transformation of processes with high inclusion of digital therapeutics apps.

For instance,

Primary care and management of several non-communicable diseases transferred to digital mode. Several countries such as England have already started embracing telehealth for primary care and have been delivering a digital-first approach for overall healthcare provision.

However, the coronavirus pandemic created a positive and huge impact on the digital therapeutics to treat the patient illness in just a moment without direct contact. It also benefits their doctors who can use the logged-in data to analyze any gaps in the patient’s management of the disease. Using technology to better control chronic disease must become the new normal as we continue to make our way through the pandemic and even beyond.

#Digital Therapeutic Market #Digital Therapeutic Market Analysis #Digital Therapeutic Market by Application #Digital Therapeutic Market by Type #Digital Therapeutic Market Forcast #Digital Therapeutic Market Future Innovation

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US FDA publishes FAQs on registering and importing devices during pandemic

US FDA publishes FAQs and has announced the availability of temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections during COVID-19 Public Health Emergency Questions and Answers.”

It is recognized that the COVID-19 public health emergency is not only impacting public health, but also drug development programs, ongoing manufacturing operations and FDA’s ability to conduct inspections.  We also recognize sponsors and applicants have many questions related to this impact.  The agency developed this guidance to provide answers to a number of frequently asked questions”, informed the drug regulator in a statement.

The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Office of Regulatory Affairs remain fully capable of continuing daily activities, such as application assessments, including facility evaluation and certain inspection activities, while responding to public health needs related to the current COVID-19 public health emergency.  As this remains an evolving and very dynamic situation, we will continue to be flexible and transparent, it added further.

Operon Strategist assists companies and medical device manufacturersby providing consultancy services that support the registration of drug-device combination products.

We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210 and 211), Device (FDA 21 CFR part 820) and Combination Products (21 CFR Part 4).

The US FDA publishes FAQs in August, answering questions about registering, listing, and importing medical devices during the COVID-19 emergency. These should be useful to manufacturers and other interested parties, not only because of the question-and-answer format, but because they provide links to numerous other FDA guidance documents published during the pandemic and related online resources.

US FDA publishes FAQs Registering and listing medical devices and facilities.

The first FAQ describes requirements and approved procedures for registering and listing medical devices and facilities during the COVID-19 pandemic. It includes an explanation of how to confirm registration and listing information, and it also provides recommendations and guidance documents relevant to operations during the present public health emergency. The FAQ addresses topics such as how long it takes for a facility to receive its registration number, when registration is not required, and how to evaluate claims of FDA “certification.” The section headings are as follows:

Registration and Listing During the COVID-19 Pandemic

Confirming Registration and Listing Information

Registration and Listing of Certain Medical Devices for Use during the Emergency.

US FDA publishes FAQs Importing medical devices

The second FAQ looks at importing medical devices amidst the COVID-19 emergency. It addresses importation of specific devices that have been issued with Emergency Use Authorizations (EUAs) and devices for which an enforcement decision has been published in a guidance document. This FAQ also includes detailed instructions for donating medical devices, checking import status, evaluating FDA “certification” claims, and identifying contacts for import questions. Section headings are:

Importing Respirators, Face Masks, and PPE

Donating Medical Devices

Importing Other Medical Devices

Checking Import Status and Contact for Import Questions

The FDA describes the way the medical devices actively used in the context of the pandemic could be imported to the US, and also the requirements the importer shall fulfill. The most important points covered by the US FDA publishes FAQs include, inter alia, the following ones:

The FDA does not certify products – the Agency only allows products for marketing and use and adds the appropriate entries to the register. In order to check whether the particular product is FDA-cleared, the interested party may check the databases containing information about the registered medical devices and ones covered by device-specific exemptions. It is also advised to check the information about the devices placed on the market under the appropriate EUA.

Sterilizers could be imported under the special enforcement policy issued by the FDA. For devices of this type, the FDA is not going to object to certain changes.

In order to import ventilators covered by the EUA, the importer shall supplement the importation documentation with the signed EUA letter. Depending on the particular ventilator in question, the appropriate Intended Use Code (IUC) should be indicated by the importer.

Electronic thermometers could be also placed on the market under the special enforcement policy which simplifies regulatory procedures related to such devices due to the important role they are playing in addressing the COVID-19 outbreak. In particular, in some cases, thermometers could be marketed without registration and listing. Remote ophthalmic assessment and monitoring devices could be imported under the simplified procedure too, providing that the appropriate Intended Use Code has been indicated.

Infusion pumps and accessories thereto are also covered by the special enforcement policy allowing the importers and manufacturers of such devices to waive certain regulatory requirements related to the registration and listing.

COVID-19 tests, which are regulated as in vitro diagnostic medical devices, could be imported either under the Emergency Use Authorization or under the special policy for diagnostic tests for corona virus intended to be used in the context of the public health emergency. Thus, the appropriate Intended Use Code should be indicated in the importation documentation. Each imported medical device regulated by the FDA should be assigned with the appropriate entry number.

According to the general rule, the entity performing operations with medical devices should be duly registered with the FDA. In the course of such registration, an entity should describe the operation it performs and to provide a list of medical devices. In case if due to the type of the device in question should be subject to mandatory pre-market approval, the interested party shall submit the appropriate application to the FDA. Each entity shall also pay the annual registration fee irrespectively of the applications filed.

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US FDA publishes FAQs

Contact details –Phone no -  9325283428Mail  -

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Virtual Clinical Trial

Clinical Research Remote Summary

A new method of collecting safety and efficacy data from clinical trial participants to from study start-up through execution. The trial takes full advantage of technologies and online social engagement platforms to conduct each stage with the comfort of the patient.

The COVID 19 pandemic has rapidly challenged the pharmaceutical industry to implement remote clinical research. The industry lacks extensive experience with distant methods of clinical trials. The opportunity for the remote clinical trial has been recognized for some time. The industry is making indoors with this operational paradigm. Remote data collection will not be feasible for all types of measurements. A decision tree should be defined to identify which clinical measure translates to candidate remote measurement. Regardless of the clinical to remote measurement pathway taken, several activities are required to ensure that the remote data that is collected is safe, usable, and valid. Attention must also be given to measurement frequency and schedule assessment for remote measurement. Many connected devices that can measure data can record it continuously. Collecting clinical trial assessment in remote mode is different and have their advantages as well as disadvantages.

  FDA guidance on remote monitoring 

FDA plays a crucial role in protecting the united states from threats such as emerging infections including pandemics such as coronavirus. FDA is issuing this guidance to provide general consideration to assist sponsors in assuring the safety of participants, maintains compliance, and minimizing risk to trial integrity. FDA guidance on the conduct of the clinical trial of the medical product during COVID-19 pandemic is important, in case to know about the drug safety or proper usage.

The progress of adopting a decentralized clinical trial model and remote data collection was limited before the COVID-19 pandemic. However, the rapid adoption of telehealth during COVID-19 when the remote doctor visits become vital. Remote monitoring clinical trials during COVID-19 become crucial. The rapid rate of adoption to remote measurements and sharing the experience and results can accelerate the field of clinical trials. During COVID-19 pandemic, many details still need to be figured out regarding remote monitoring. However, the current situation could be an opportunity to revamp the conventional clinical trial models.

   Virtual clinical trials can satisfy the need for vigorous clinical trials by using distributed technologies. Virtual clinical trials can reduce cost, shorten trial timelines, increase protocol adherence, and boost recruitment members and participants diversity. These trails provide access to the participant to the research team through a technology’s web portal. Although complete development regarding the collection of a lot of data. This approach holds growth potential. It is also critical in the social component of clinical trials along with the trust that can develop between participants and researchers. A VR based communication hub for VCT should reinsert some human of elements to these studies Use of VR to support interpersonal relation between participant and researchers are important for the single-blind study.

 . 

References: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency - FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307062/ - Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487205/ - Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6969384/ - A Virtual Home for the Virtual Clinical Trial https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7051945/ - Conducting a Virtual Clinical Trial in HER2-Negative Breast Cancer Using a Quantitative Systems Pharmacology Model With an Epigenetic Modulator and Immune Checkpoint Inhibitors

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Coronavirus updates: Wuhan reports first day with zero new cases

Health workers screen a patient for coronavirus on March 18 at a drive-through testing site in Arlington, Virginia.

Drew Angerer/Getty Images

For the most up-to-date news and information about the coronavirus pandemic, visit the WHO website.

COVID-19, the disease caused by the novel coronavirus, has rapidly spread and reached the stage of international pandemic. Cities, states and countries have mandated quarantines. Health care systems are scrambling. Entire industries have shut down. Companies have switched to working from home and tried measures to help hourly workers. Tech giants have been hit by supply chain problems. Social media networks have wrestled with the spread of misinformation and conspiracy theories.

Get all the latest on the coronavirus that’s now been declared a pandemic.

The spread of COVID-19 has progressed at a blistering pace. If you’re wondering what a coronavirus is, what the symptoms are and how you can protect yourself, head over to CNET’s FAQ. We’ve created a timeline for the virus below, in reverse chronological order, and will update it with the latest developments each day.

Coronavirus timeline

March 19

FDA approves ‘compassionate use’ for several patients, Trump says

During a briefing Thursday, US President Donald Trump said his administration has “slashed red tape” to develop vaccines and therapies for coronavirus as fast as possible. The president also said the US Food and Drug Administration has approved “compassionate use” for several coronavirus patients, allowing them to try experimental drugs that haven’t yet been approved by the FDA. 

Also during the briefing, FDA Commissioner Stephen Hahn said the agency is looking at drugs already approved for other uses, including an anti-malaria drug called hydroxychloroquine, as possible treatments for coronavirus. However, he stressed that experts would be doing this in the setting of a clinical trial. 

March 18

Wuhan reports first day with zero new cases

The central Chinese city of Wuhan is reporting zero new COVID-19 cases for the first time since the outbreak began in December last year. According to CGTN, a Chinese media service, the Chinese mainland reported zero new domestically transmitted cases, marking a turning point in the battle against the virus at the outbreak’s epicenter. 

NYSE moves to digital trading

The New York Stock Exchange will move temporarily to fully electronic trading as of market opening on Monday, March 23. Facilities closing include the NYSE equities trading floor in New York, NYSE American Options trading floor in New York and NYSE Arca Options trading floor in San Francisco. NYSE called it a “precautionary” measure.

Deferring tax payments will keep $300B in the economy

The US Treasury and the IRS say deferring of tax payments from April 15 to July 15 “will result in about $300 billion of additional liquidity in the economy in the near term.” Individuals owing $1 million or less and corporations owing $10 million or less may take advantage, but they must still file their tax returns by April 15.

US Census collection delayed

Field collection of the 2020 US Census is being postponed, with in-person teams suspended until April 1. In late May, census takers are set to visit households that have not yet responded. “As we continue to monitor the evolving COVID-19 outbreak, we will adjust census taker and survey operations as necessary in order to follow the guidance of federal, state and local health authorities,” the Census Bureau said.

It’s possible to complete the Census online, however. The bureau encourages filling it out as soon as possible.

UK shuts schools starting Friday

All schools in the UK will be closed from Friday until further notice, UK Prime Minister Boris Johnson announced on Wednesday. Schools will be required to make provisions for the children of key workers, including doctors and nurses, and must also continue to care for the most vulnerable children. Children who receive free school meals will be given vouchers to ensure they still are able to claim a free daily lunch. No school exams will take place this year. Johnson has asked parents not to leave children with older grandparents or those in other vulnerable groups.

FCC bends rules on remote learning and health

The FCC will allow healthcare providers, schools and libraries to accept gifts like Wi-Fi hotspots, networking equipment and other equipment and services from internet providers for telehealth and remote learning efforts during the coronavirus pandemic, Chair Ajit Pai tweeted. The FCC’s Wireline Competition Bureau is waiving the gift rules for its Rural Health Care (RHC) and E-Rate programs until Aug. 30.

Trump invoking Defense Production Act

President Trump said he’s invoking the Defense Production Act, which allows him to expedite and expand production of critical equipment — such as ventilators, respirators and protective gear — from the US industry. “It can do a lot of good things if we need it and we will have it all completed, signing it in just awhile,” Trump said at a coronavirus task force briefing.

Americans asked to wait on elective medical procedures 

Also at the briefing, Vice President Mike Pence called on Americans to postpone all elective medical procedures. 

Naval hospital ships will be deployed 

Secretary of Defense Mark Esper said he has directed the Navy hospital ships Mercy and Comfort to deploy “to increase the nation’s medical capacity.” Each ship contains 1,000 beds, a pharmacy, operating rooms and a medical laboratory. It is unclear at this point exactly how the ships will be used once deployed.

US closes border with Canada to ‘non-essential’ traffic

The US will close its northern border with Canada to all “non-essential” traffic amid the pandemic, President Trump announced. “We will be, by mutual consent, temporarily closing our Northern Border with Canada to non-essential traffic,” the president tweeted. “Trade will not be affected.”

Australia announces global travel ban

Australian Prime Minister Scott Morrison has announced an indefinite ban on international travel across the entire globe for Australian citizens and residents. “Do not go overseas,” Morrison said in a press conference, adding the most cases the nation has seen have been from Australians returning from an international trip.

Australia has also banned non-essential indoor gatherings of 100 or more people, with the outdoor limit still set for 500. Morrison called for hoarders of household goods to stop, labelling them “un-Australian.”

Anzac Day services for April 25 will now only be held online.

March 17 

Coronavirus spreads to all 50 US states

With West Virginia reporting its first case of coronavirus, COVID-19 has now spread to all 50 states in the US.

Kansas closes schools through summer

Kansas Gov. Laura Kelly on Tuesday ordered all public schools serving kindergarten through high school students to be closed for the rest of the academic year.  Officials plan to continue educating students and have formed a panel produce lesson plans and other guidance for schools.

Stocks up on Trump economic plans

Stocks rose as US President Donald Trump promised he’s “going big” and preparing to ask for an $850 billion aid package to blunt the economic impact of the coronavirus. Treasury Secretary Steven Mnuchin said the Trump administration wants to get emergency funds in Americans’ pockets “immediately.”

“Americans need cash now,” Mnuchin said during a White House press briefing. “I mean now in the next two weeks.” The proposal to send checks requires congressional approval. The previous day saw one of the worst drops in the market’s history as the US and the world continued to react to the pandemic’s spread.

New York halts state debt collection

Gov. Andrew Cuomo announced New York won’t be collecting any state debts for at least the next 30 days. This includes “student debt, medical debt & other state-referred debt,” Cuomo tweeted.

Tax day payments postponed

The IRS has extended its tax payment due date by 90 days, said Treasury Secretary Steven Mnuchin. People are still encouraged to file on time by April 15, but you can delay payments if you owe money to the IRS, with interest and penalties being waived.

MGM resorts close across Vegas

Some of the biggest resorts and casinos in Las Vegas have closed, with MGM Resorts shutting down Bellagio, Aria, MGM Grand, Mandalay Bay, Delano, Mirage, New York New York, Luxor and Excalibur. The company won’t take reservations prior to May 1. 

“We will plan to reopen our resorts as soon as it is safe to do so,” Jim Murren, CEO of MGM Resorts, said. 

UK government warns against travel

British residents were advised against “all but essential international travel.” The government sent a travel advisory email adding that “any country or area may restrict travel without notice.”

March 16

Trump announces new guidelines for next 15 days

Trump announced a series of guidelines for all Americans to follow over the next 15 days:

Avoid gatherings of more than 10 people.

Avoid discretionary travel like shopping trips and social visits.

Avoid bars and restaurants and food courts — instead use drive-through, pickup and delivery options.

Do not visit aged care facilities.

If you work in health care, pharmaceutical or food supply, “you have a special responsibility to maintain your normal work schedule.”

If someone in your house has tested positive, the entire household should stay home.

Older people and those with underlying health conditions should stay home.

The guidelines also recommend states with evidence of community spread should close all bars, restaurants, food courts, gyms and indoor and outdoor venues. “It’s just so contagious,” Trump said during a White House briefing.

Trump said he was tested for the coronavirus “very late Friday night,” with the results coming back negative.

San Francisco Bay Area locks down

San Francisco Bay Area residents will be required to stay home except for essential needs due to the spread of the coronavirus, Mayor London Breed announced Monday at a joint press conference with leaders of the surrounding six counties. The measures go effect Tuesday to slow the spread of COVID-19, although “necessary government functions and essential stores” will still be open.

New Jersey ‘strongly discourages’ travel between 8 p.m. and 5 a.m.

A curfew is being recommended by New Jersey Gov. Phil Murphy for between 8 p.m. and 5 a.m., saying “This will remain in effect for the foreseeable future. We want everyone to be home, and not out.” As of 8 p.m. PT Monday, all gatherings of over 50 are banned, and all movie theaters, gyms, casinos and racetracks will be shut down. Essential businesses like supermarkets, grocery stores, medical offices, gas stations and pharmacies may remain open later than 8 p.m., Murphy said.

Microsoft’s Bing launches tracking map

Microsoft’s search tool Bing has launched its own web portal to track the spread of coronavirus globally. It also links to news articles.

G7 leaders pledge to do ‘whatever is necessary’ to fight pandemic

In a statement on Monday, world leaders said they’re committed to working together in order to protect people during the coronavirus pandemic. The Group of Seven — a intergovernmental organization of seven countries including the US — said it will pool “epidemiologic and other data to better understand and fight the virus,” as well as “forcefully address” the economic impact of the outbreak.

Qantas refunding all flights

One day after Australian Prime Minister Scott Morrison announced a mandatory 14-day quarantine on anyone flying into Australia — aside from those from Pacific islands — Qantas has said it will refund all flights that have been booked for travel up to May 31 in Qantas store credit.

Europe proposes ban on incoming travel

The president of the European Commission on Monday proposed a month-long ban on nonessential incoming foreign travel to the EU. Individual governments would have to agree to the restrictions, which would apply to travelers from outside the EU, but not to British citizens. 

“Here in Europe we are heavily affected by the virus and we know that everything that reduces social interaction also reduces the speed of the spread of the virus,” said President Ursula von der Leyen. “The less travel, the more we can contain the spread of the virus.”

NY, NJ and CT take join action

The governors of New York, New Jersey and Connecticut on Monday said they’re taking joint regional action to reduce the spread of COVID-19. Gyms, movie theaters and casinos in all three states will be temporarily closed starting Monday evening. Bars and restaurants will be restricted to take-out and delivery only. Also, in line with CDC recommendations, gathering are being restricted to no more than 50 people throughout the three states. 

March 15

CDC recommends eight-week hold on public events

The CDC recommended that US gatherings of 50 or more be canceled or postponed for the next two months. 

“CDC, in accordance with its guidance for large events and mass gatherings, recommends that for the next eight weeks, organizers (whether groups or individuals) cancel or postpone in-person events that consist of 50 people or more throughout the United States,” the CDC said in a statement. The recommendation does not apply to the day-to-day operation of schools, businesses or institutions of higher learning, the CDC said. 

Fed slashes rates to almost zero 

The Federal Reserve slashed interest rates a full percentage point to near-zero to prop up the economy amid the coronavirus outbreak. “Consistent with its statutory mandate, the Committee seeks to foster maximum employment and price stability,” the Federal Reserve said in a statement. The effects of the coronavirus will weigh on economic activity in the near term and pose risks to the economic outlook.

Italy reports sharp one-day increases 

Italian health officials reported 3,590 more cases Sunday, the country’s largest single-day increase so far, and 368 deaths (also a single-day record). Total cases in the country total more than 24,000, with deaths at more than 1,800. That’s the most outside China. 

California night clubs, wineries and bars ordered closed

California Gov. Gavin Newsom on Sunday ordered the closure of all “bars, nightclubs, wineries, brewpubs and the like” to combat the spread of coronavirus. Restaurants are exempt from the order because they’re considered an essential business, but they will be required to halve their occupancy to maintain appropriate social distancing.

New York City closes schools

New York City’s public school system will shut down to stem the spread of the coronavirus, New York Gov. Andrew Cuomo announced. The system, the largest in the country with more than 1 million students, previously shut down nine public schools because a student or school personnel had tested positive for the virus.

No public Easter celebrations, Vatican says 

The Vatican said its traditional Easter week celebrations would be held without worshippers this year. “Because of the current global public health emergency, all the liturgical celebrations of Holy Week will take place without the physical presence of the faithful,” the Prefecture of the Pontifical Household said in a statement.

Also on Sunday, Pope Francis left the Vatican to visit two important pilgrimage sites in Rome and to pray all who are either sick and caring for the sick, a Vatican statement said. “With his prayer, the Holy Father pleaded for an end to the pandemic that has struck Italy and the world. He also implored the healing of the many sick people, remembered the numerous victims of these past days and asked that their families and friends might find consolation and comfort.” 

Germany closes land borders 

As cases in Germany reached 5,000, the country announced that it will temporary close its borders with France, Switzerland, Austria Luxembourg and Denmark starting 8 a.m. local time on Monday. Goods will still move freely and commuters will be allowed to cross borders for work. Interior Minister Horst Seehofer said the government needed to “disrupt the chains of infection” to contain the spread of the disease and “to do that, we have to limit not only large events and social contact, but also the movement of people.”  

Former Schiff aide tests positive

Rep. Adam Schiff (D-California) said Sunday that a former aide on his staff has tested positive for coronavirus. Schiff said in a tweet that the former staffer likely contracted the virus after leaving his office 10 days ago and that no other staffers are exhibiting any flu-like symptoms.

In Rome on March 15, Pope Francis prays in S. Marcello al Corso church, where home to a crucifix that in 1552 was carried around Rome in a procession to stop the great plague.

Vatican Media/AFP via Getty Images

March 14

Spain, France impose restrictions

After imposing a lockdown Friday on the Catalonia region, the Spanish government on Saturday ordered all the country’s citizens not to leave their homes except to go to work, buy food, seek health care or help those in need of care, The New York Times reported. The Times also said France has ordered all “non-indisensible” businesses to close as of midnight. That includes bars, restaurants and movie theaters but excludes grocery stores, banks and gas stations. Meanwhile, the paper noted, Poland said that come Sunday, it would seal its borders to everyone except citizens, and Denmark said all foreigners without an essential reason for visiting would be refused entry. In a move earlier in the week, all of Italy had already been sealed off, and only banks, grocery stores and pharmacies remain open there.

Trump tests negative; US expands travel ban; House OKs relief package

US President Donald Trump tested negative for the coronavirus, his doctor said late Saturday, according to The Washington Post. During a Saturday morning press conference, Trump said he’d been tested for the coronavirus Friday night, with the results still to come. Several people Trump has had contact with at his Mar a Lago property have tested positive.

Also at that press conference, Vice President Mike Pence said the federal government is extending a ban on travel from Europe to the US, with the ban now including Britain and Ireland. That move is set to go into effect at midnight on Monday.

On Friday, the US House of Representatives passed a major relief package for people affected by the coronavirus. Among other things, the package ensures paid sick and emergency leave, enhances unemployment insurance, and increases federal funding for Medicaid and for food assistance programs.

New York Gov. Andrew Cuomo reported the first death in New York City. Cuomo said the victim was an 82-year-old woman with a preexisting respiratory disease. The New York Times later clarified that the woman died in Brooklyn. Later still, officials announced the second death in New York state, a 65-year-old man north of Manhattan with “significant health problems,” the paper noted.

Apple continues coronavirus efforts

Apple said it’s closing all its stores outside of Greater China until March 27 due to coronavirus worries. The company also said it will accept COVID-19 and coronavirus-related apps only from “recognized entities such as government organizations, health-focused NGOs, companies deeply credentialed in health issues, and medical or educational institutions.”

March 13

AMC has capped its movie theaters at 50% capacity, with no more than 250 seats to be filled per movie, so those inside can practice social distancing; the Everest climbing season has been shut down early; Washington, DC, is banning gatherings of 250 or more people; and Boston closes all schools for six weeks.

Trump to host talks with G7 leaders

US President Donald Trump spoke with French President Emmanuel Macron, discussing how the two nations could work together to stop the coronavirus pandemic, with Trump agreeing to “host a videoconference on the coronavirus with all of the G7 leaders early next week,” Judd Deere, special assistant to the president and White House deputy press secretary, announced late Friday. The G7 includes the US, France, the UK, Germany, Canada, Italy and Japan.

Trump declares national emergency

Trump declared a national emergency, saying the move will open access to $50 billion in federal funds for states, territories and localities in the fight against the coronavirus. The president said he’ll “most likely” be personally tested for the coronavirus soon.

Trump also said the UK might have to be included in the US’ European travel ban due to more cases being reported there overnight, and he announced that Google is helping build a website for coronavirus information. Later, the president tweeted that cruise line companies Carnival, Royal Caribbean, Norwegian and MSC have agreed to suspend outbound cruises for 30 days from midnight.

Trump Friday evening declared Sunday, March 15 as a “national day of prayer.”

US looks at Families First Coronavirus Response Act

House Speaker Nancy Pelosi said she reached agreement with the Trump administration to pass the Families First Coronavirus Response Act that she said will protect families. Trump said Friday evening he “fully supports” the legislation, which he said covers free coronavirus tests and paid sick leave.

San Francisco bans evictions, prohibits gatherings of 100 people

San Francisco Mayor London Breed announced a moratorium on evictions caused by “loss of income related to a business closure, loss of hours or wages, layoffs, or out-of-pocket medical costs caused by the coronavirus pandemic.”

“Protecting public health means keeping people secure in their homes,” Breed said. The mayor also prohibited all non-essential gatherings of 100 or more people effective immediately.

March 12

US states have begun banning large gatherings of people with some exceptions; France has closed all schools and universities until further notice; head coach of English soccer club Arsenal Mikel Arteta has been diagnosed with COVID-19, with the entire first squad now in self-isolation; all Smithsonian Museums across New York and Washington DC, as well as the National Zoo, will close March 14; and a second Utah Jazz player, Donovan Mitchell, has tested positive for the coronavirus, according to ESPN.

Sophie Trudeau tests positive for COVID-19

Sophie Trudaeu, former TV host and wife of Canadian prime minister Justin Trudeau, has tested positive for COVID-19. According to tweets by the prime minister on Wednesday, Sophie was experiencing mild flu-like symptoms upon return from the United Kingdom. As a precaution, the prime minister will go into self-isolation for 14 days. 

Disneyland is closing as California halts gatherings of 250 or more

California Gov. Gavin Newsom introduced new guidelines that say all private and public gatherings of 250 people or more should be canceled for the rest of March. Newsom said this didn’t apply to casinos, card rooms, theaters or Disneyland “because of the complexity of their unique circumstance,” and he added that he’d spoken with former Disney CEO Bob Iger on March 11 and decided the Disney theme parks in Anaheim could remain open. Nevertheless, later Thursday, Disney Parks decided to shut down those venues till the end of the month.

It’ll be closing the doors of the Disneyland and California Adventure theme parks as of March 14, though the Downtown Disney shopping and dining area will remain open. Disney’s three hotels at Disneyland — the Disneyland Hotel, Paradise Pier and the Grand Californian — will remain open until March 16 to allow for guests to make travel plans. Disney Parks said there have been no reported cases of COVID-19 at Disneyland.

Disney World and Disneyland Paris are closing

Following the announcement of Disneyland closing, the Disney company said Walt Disney World and Disneyland Paris would also be closing on Sunday, March 15, through the end of the month. This includes the Disneyland Paris and Walt Disney Studios parks in France, and the Magic Kingdom, Epcot, Animal Kingdom, Disney’s Hollywood Studios, Typhoon Lagoon and Blizzard Beach parks in Orlando, Florida.

The Disney Village and Disney Springs shopping and dining areas and the multiple hotels on each property will remain open, said ABC, which is owned by Disney. Disney Cruise Line will also suspend new departures as of March 14 for the remainder of the month.

New York stops gatherings of 500, including Broadway shows

New York Gov. Andrew Cuomo announced that all gatherings of 500 or more people should stop, with the rule going into effect Friday. The exception is Broadway theaters, which’ll be closed as of 5 p.m. ET tonight.

Ohio bans gatherings of 100-plus people

Ohio Gov. Mike DeWine announced a ban of 100 or more people in a single room or single space, including stadiums, arenas, conference rooms, meeting halls, cafeterias, auditoriums, parades, fairs and festivals but not including airports, bus and train stations, medical facilities, malls, grocery stores, restaurants, factories, offices and schools where there can be large groups but “it is unusual for them to be within an arm’s length of one another.” The Ohio ban also doesn’t include religious gatherings. Ohio has five confirmed cases of COVID-19.

US Capitol reportedly stops all public tours

The US Capitol will reportedly halt all public tours through at least the end of March. The decision was made jointly by congressional leaders, Capitol security officials and medical staff, Politico reported. By the end of the week, the Capitol complex is expected to be restricted to official business only. 

Princess Cruises halts operations

The Carnival-owned cruise line said Thursday that all 18 of its cruise ships will cease operations for 60 days, starting Thursday. “Those currently onboard a cruise that will end in the next five days will continue to sail as expected through the end of the itinerary so that onward travel arrangements are not disrupted. Current voyages that are underway and extend beyond March 17 will be ended at the most convenient location for guests, factoring in operational requirement,” the company said in a statement.

March 11

Coronavirus has been declared a pandemic, E3 has been canceled, the US House and Senate may announce a halt to tours of the US Capitol, production on CW series Riverdale has been shut down, and the GLAAD Awards have been cancelled.  

WHO declares outbreak a pandemic

The World Health Organization has officially declared the coronavirus outbreak a pandemic. Tedros Adhanom Ghebreyesus, WHO director-general, made the announcement Wednesday, saying that “pandemic is not a word to use lightly or carelessly.”

Trump suspends travel from Europe to US

No travelers will be allowed to enter the US from most of Europe for 30 days, the president said during an evening briefing. “These restrictions will be adjusted subject to conditions on the ground,” Trump said in a rare televised address from the Oval Office. “There will be exemptions for Americans who have gone through appropriate screenings.”

Tom Hanks, wife Rita Wilson test positive

In what is perhaps the highest-profile coronavirus case yet, the actor shared on Instagram that he and his wife tested positive for the illness. They will self-isolate until instructed otherwise. 

Italy to close most stores

Italy is closing all stores apart from food shops and chemists, according to a report.

NBA suspends rest of season

The rest of the NBA’s 2020 season is suspended indefinitely, following follows Utah Jazz player Rudy Gobert testing positive for the coronavirus. 

Earlier in the day, the Golden State Warriors barred fans from home basketball games, announcing in an official statement that its March 12 game vs. the Nets at San Francisco’s Chase Center will be played without fans in attendance. Fans with tickets to this game will receive a refund in the amount paid. All events though March 21 will also be canceled or postponed. 

NCAA limits number of fans at games

The NCAA announced that only essential staff, players, coaches, and limited family members will be able to attend the 2020 men’s and women’s NCAA championships. “While I understand how disappointing this is for all fans of our sports, my decision is based on the current understanding of how COVID-19 is progressing in the United States,” NCAA President Mark Emmert said in a statement. This includes holding March Madness without any fans in attendance.

Annual NAB Show canceled 

The annual Las Vegas show is off. “NAB is evaluating a number of alternatives to the April show,” organizers said in a statement. 

E3 2020 canceled

Rumors have been swirling for weeks that the world’s biggest video game trade show would be canceled. On Wednesday, the Entertainment Software Association, the group behind E3, called the event off. The ESA said it’ll look into conducting an online showcase in place of E3 in June. 

Trump: We are putting together a plan

Trump says the government is “putting into policy a plan to prevent, detect, treat and create a vaccine against CoronaVirus to save lives in America and the world.” Trump said he is prepared to use the government’s “full power” to deal with the spread of COVID-19. Trump will be addressing the nation at 6:00 p.m. PT from the Oval Office.

CES Asia 2020 postponed

CES Asia, the sibling of the world’s biggest tech trade show, CES, was scheduled to take place June 10-12 in Shanghai but has been postponed by the organizing committee, the Consumer Technology Association. No new date was announced.

“Our decision reflects the concerns of our stakeholders including exhibitors, buyers, media and speakers. Given the evolving global concerns about and impact of the coronavirus (COVID-19), we feel this is the best decision for everyone involved, ” the Consumer Technology Association said in a statement.  

Making tax day less taxing

Trump suggested on Monday that his administration might give wage earners a “very substantial relief” in the form of a payroll tax cut. Trump might also be looking to extend the April 15 deadline for US residents to file their federal taxes, The Wall Street Journal reported. A filing extension would effectively serve as a “bridge loan” for individuals and businesses affected by the virus since they wouldn’t face fines or interest penalties.

US cases hit 1,000

The US has reported over 1,000 cases of COVID-19. The increasing number of positive cases comes against a backdrop of increased scrutiny on the US response, after reports showed the federal government “missed chances” to contain the outbreak early. 

Britain’s health minister infected

Nadine Dorries, the British health minister, has confirmed she tested positive for the coronavirus. According to the BBC, Dorries self-isolated at home and had started tracing people she had contact with. The same day she began showing symptoms, she had attended an event at which British Prime Minister Boris Johnson also was present. 

Dorries took to Twitter late on Tuesday to thank her followers for “many good wishes.”

Thanks for so many good wishes. It’s been pretty rubbish but I hope I’m over the worst of it now. More worried about my 84yo mum who is staying with me and began with the cough today. She is being tested tomorrow. Keep safe and keep washing those hands, everyone.

— Nadine Dorries

(@NadineDorries) March 10, 2020

Australia bans travel to Italy, announces AU$2.4B package

Australian Prime Minister Scott Morrison held a press conference Wednesday morning local time, announcing that Australians will be banned from traveling to Italy as of 6 p.m. AEDT on March 11. Morrison also provided details on how a AU$2.4 billion ($1.6 billion) response package will be spent, including on establishing 100 pop-up fever clinics across the nation; providing free health sessions with doctors over FaceTime, Skype and WhatsApp video calls; and helping support aged care facilities. The government is still finalizing some of the measures, with Morrison saying the package is about “keeping Australians in jobs, and keeping business in business.”

AU$30 million will be spent on research into vaccines and treatments. The Australian government said there’s “no point” in being tested for COVID-19 right now even if you do feel sick unless you’ve traveled or been in contact with someone who is a confirmed case.

Meanwhile, another three cases were diagnosed in Melbourne on Wednesday — all three patients had recently traveled from the US to Australia.

March 10

Massachusetts declared a state of emergency, with 51 new cases reported and a total of 92 in the state. And in Nevada, buffets across Las Vegas are shutting down starting Sunday, at hotels including the Aria, Bellagio, MGM Grand, Mandalay Bay, Mirage, Luxor and Excalibur.

Zuckerberg works to increase testing in the Bay Area

The Chan Zuckerberg Initiative, owned by Facebook CEO Mark Zuckerberg and his wife, Priscilla Chan, are working with Stanford University to “quadruple UCSF’s COVID-19 testing and diagnostics capacities by funding the acquisition of two state-of-the-art FDA-approved clinical diagnostic machines.”

EU pledges 25 billion euros for coronavirus response

The European Union is setting up a 25 billion euro ($28 billion) investment fund to help address the financial crisis caused by the spread of COVID-19, Reuters said Tuesday. The European Parliament will be asked to finance the fund with 7.5 billion euros this week, European Commission President Ursula von der Leyen announced at a news conference. 

Trump hasn’t been tested for coronavirus

Trump confirmed he hasn’t been tested for COVID-19 because he’s feeling “extremely good” and has no symptoms. During a press conference Tuesday afternoon, Vice President Mike Pence said he and Trump will continue shaking hands with people.

New York sets up containment zone

The state of New York has created a “containment zone” in the city of New Rochelle just north of Manhattan, Gov. Andrew Cuomo said. The zone falls within “a 1 mile radius around the site of the most cases in New Rochelle,” Cuomo said on Twitter, adding that the city has the “biggest cluster of coronavirus cases in the state.” In the zone, large gathering places, including schools and places of worship, will be closed from March 12 till March 25. The National Guard will deliver food to those living in the zone, and a temporary testing facility has been set up. The move comes as New York announced another 31 cases in the state, for a total of 173.

Coachella and Stagecoach music festivals canceled

Coachella said the festival, originally scheduled for April 10-19, has been rescheduled for two weekends in October — Oct. 9-11 and 16-18. The corresponding Stagecoach festival will take place on Oct. 23, 24 and 25. Festival organizers say refunds will be given for those who can’t attend on the new dates.

Now playing: Watch this: Coronavirus and COVID-19: Everything you need to know

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March 9

Selling overwhelmed the US stock market, triggering an automatic halt that paused trading for 15 minutes, amid fears over the virus’ effect on the global economy. Sliding oil prices and a fall in Treasury yields contributed to the selling. Stocks rebounded when trading resumed, but then resumed sliding. The major indexes were off by more than 7% for the day. As measured by the S&P 500, stocks are down more than 15% since the beginning of the year, shortly after the new coronavirus was identified.

In Silicon Valley, companies urged employees to work from home to prevent the spread of the coronavirus. Santa Clara County, where many US tech giants are headquartered, and the San Francisco Bay Area more broadly, are the epicenter of the outbreak in California, the most populous state. Tech companies have said they’ll continue paying hourly staff during the outbreak. 

Meanwhile, sporting events like the lighting of the Olympic torch in Greece have reportedly been closed to the public, while the Serie A soccer tournament in Italy has been suspended.

Trump and Pence announce guidelines, more tests, financial help

President Trump said he will be announcing “very substantial relief” on a payroll tax cut “that’s a huge number,” as well as giving help to hourly wage earners and small businesses. During a White House press conference March 9, Trump said he’s been working with the airline, cruise ship and hotel industries because “we want people to travel to certain locations and not to other locations.”

Also speaking during the conference, Pence said all travel from China into the US has been suspended, while there are travel advisories for portions of South Korea and Italy, with all passengers coming from those countries to be screened on arrival in the US. Pence said commercial labs have brought a test forward and are making it available. Also, all state labs have a test available.

Pence said the Grand Princess cruise ship has docked in Oakland, California, with the 21 infected people in isolation. His team was hoping to disembark California residents to Travis Air Force Base that day, and made arrangements with Canada and the UK to take their passengers back. Those passengers were to be transported directly to the tarmac and flown home on chartered planes.

Trump didn’t respond to questions about whether he’s been tested. Pence hasn’t been tested, and said he will find out if Trump has. The guidance was to be released that evening on coronavirus.gov. The White House has also given additional guidelines to nursing homes around the country, with the virus now present in 35 states and the District of Columbia.

Italy shuts down entire country

Italy’s population of 60 million is now under restrictions, with Prime Minister Giuseppe Conte banning public gatherings and travel except for work and emergencies.

Qantas slashes international flights

Australian airline Qantas announced a series of changes to its flights due to the coronavirus, including grounding eight of its largest aircraft, the A380, until September. It’s also rerouting its Sydney-Singapore-London flights to go through Perth instead of Asia and delaying the launch of its new Brisbane-Chicago route. Its budget airline, Jetstar, has suspended flights to Bangkok (it suspended flights to Seoul last week) and reduced flights to Vietnam and Japan by almost half. 

Seattle confirms three more deaths

King County, home to Seattle, confirmed 33 new cases of coronavirus and three more deaths, bringing total deaths in the county to 20 and in the state of Washington to 22. 

Justice Department warns price gougers

The US Department of Justice warned that anyone found to be fixing prices or rigging bids of personal health protection equipment like gloves and face masks could face criminal prosecution.

FTC warns seven companies on cure and prevention claims

The US Federal Trade Commission and Food and Drug Administration sent warning letters to seven companies for advertising products that they falsely claim can cure or prevent coronavirus, including Silver Lozenges, herbal products, colloidal silver products, essential oils and frankincense.

NASA worker reportedly infected 

The NASA Ames Research Center in Silicon Valley in California is reportedly asking employees to work from home until further notice after one tested positive for COVID-19. The facility works on advanced computing, aerosciences and astrobiology. NASA didn’t immediately respond to a request for comment.

March 8 

In the US, coronavirus cases hit 500, with the worldwide case numbers topping 100,000. A full breakdown can be found using the Johns Hopkins case tracking tool. 

Sen. Ted Cruz in isolation US Sen. Ted Cruz released a statement Sunday detailing his interaction with a person who tested positive for COVID-19. Given the esposure, Cruz said he has decided to remain at his home in Texas for 14 days. The interaction occurred at the Conservative Political Action Conference approximately 10 days earlier. According to his statement, Cruz feels “fine and healthy.”

US State Department: ‘Avoid cruise ships’ The US State Department is advising travelers to forgo cruise ship travel, particularly those with underlying health conditions. In an update to its travel site March 8, the department said the “CDC notes increased risk of infection of COVID-19 in a cruise ship environment.”

The warning came as the Grand Princess cruise ship, which departed from San Francisco on a trip to Hawaii, was scheduled to dock in Oakland, California, on Monday. At least 21 passengers were confirmed as COVID-19 positive, including 19 members of the staff. The ship itself contained approximately 3,500 people and was to undergo a 14-day quarantine when it docked March 9. Passengers wouldn’t be required to stay on the vessel but would be moved to military bases around the country, according to CBS News.

Italy lockdown  The Italian government signed a decree ordering millions of people into lockdown across the northern part of the country. The order put the northern region of Lombardy, as well as 14 other regions, under travel restrictions, CNN reported. The lockdown quarantined tens of millions of citizens. Italy’s outbreak is the worst outside Asia and the worst in Europe, with over 7,000 cases and 300 deaths.

Public health checks have kicked in worldwide. Here, health workers take a man’s temperature before a soccer game in Italy in early March.

Gabriele Maricchiolo/NurPhoto via Getty Images

March 7: In the US, New York Gov. Cuomo declared a state of emergency and announced that the number of cases in the state had risen to 76. Elsewhere, Washington DC Mayor Muriel Bowser reported the US capital’s first infection, and Florida and Georgia both reported new coronavirus cases, a day after the Florida Department of Health announced the first deaths on the East Coast.

Also near DC, the American Conservative Union said an attendee at last week’s CPAC event had tested positive for the coronavirus, CNN reported. Trump and Pence were among those at the conference. The White House told CNN that “at this time there is no indication that either President Trump or Vice President Pence met with or were in close proximity to the attendee.” That person was receiving medical care in New Jersey. And Amtrak said its Acela nonstop train service between New York and Washington would be suspended from March 10 to May 26.

In the western US, Arizona, California and Oregon reported new cases, and an employee at a downtown Seattle Starbucks was diagnosed with COVID-19. The employee was quarantined at home, Starbucks told USA Today. “We quickly activated our protocols, immediately closing the store and initiating a deep clean overnight, following all recommended guidelines from the City of Seattle and King County public health authorities,” the company told the news service in a statement. It’s the first US coronavirus case reported by Starbucks, according to USA Today. Earlier in the week, Redmond, Washington-based Microsoft said two of its employees had been diagnosed with COVID-19.

The head of Italy’s co-governing Democratic Party, Nicola Zingaretti, said in a tweet that he’d been diagnosed with COVID-19, adding that he’s fine but has to remain at home. He said on Facebook that his family was following protocols and that local health officials were contacting people he’d been in contact with, CNN reported. Also in Italy, a US Navy sailor in Naples tested positive for coronavirus, the first recorded COVID-19 case for an American service member in Europe, the Navy Times reported. 

In Iran, a member of parliament, 55-year-old Fatemeh Rahbar, died from the coronavirus, Bloomberg reported. Rahbar was the second lawmaker in Iran killed by the coronavirus and one of several politicians and government officials who’d succumbed during the outbreak, The Times of Israel reported.

On the social media front, Facebook said it’s temporarily banning face mask ads to help curb the exploitation of fears around the coronavirus.

March 6: Coronavirus cases reached the 100,000 milestone globally, while Trump signed an emergency funding package, and the South by Southwest festival got canceled. The US also saw the first coronavirus deaths on the East Coast, with the Florida Department of Health announcing that two people had died from COVID-19.

Global cases hit a milestone Confirmed global cases of COVID-19 have now topped 100,000, according to a tracker developed at Johns Hopkins University. The tracker pulls data from the Centers for Disease Control and Prevention, the World Health Organization and other local and international health authorities.

Trump signs $4 billion emergency funding package Trump signed an emergency funding package, later tweeting that he spoke to California Gov. Gavin Newsom “about the cruise ship quarantined off the California coast.” Trump said test kits had been delivered for the cruise ship.

South by Southwest gets canceled Austin, Texas-based SXSW joined a growing list of events to pull the plug amid coronavirus concerns.  The event drew 417,4000 attendees in 2019. “Based on the recommendation of our public health official and director of public health and after consultation with our city manager, I’ve gone ahead and declared a local disaster. And along with that issued an order that cancels SXSW this year,” Austin Mayor Steve Adler said in a press conference, later calling the cancelation “unfortunate.” The cancellation followed multiple dropouts from companies and artists slated to appear at SXSW.

Deaths on the East Coast The East Coast of the US saw its first coronavirus deaths, with the Florida Department of Health announcing that two people had died from COVID-19. Both victims had traveled internationally, the department said.

Pennsylvania, Indiana, Minnesota, Kentucky, Hawaii confirm first cases Pennsylvania Gov. Tom Wolf confirmed that two people in the state had presumptive positive test results for the coronavirus. One of them, an adult from Wayne County who recently traveled to a country with an outbreak, was at home in isolation. The other, an adult from Delaware County who recently traveled to an area in the US where the coronavirus is spreading, was also at home in isolation.

Indiana health officials confirmed the first presumptive positive case of coronavirus. The adult patient, a Marion County resident, had recently returned from a conference in Boston. Officials said he’s now in isolation and in stable condition, according to officials. An investigation was underway. Indiana Gov. Eric Holcomb declared a public emergency to ensure additional funding.

Minnesota also confirmed its first case: an “older adult” in Ramsey County who traveled on a cruise ship with a known coronavirus case. The patient developed symptoms Feb. 25 and sought health care March 5, and was in quarantine at home while recovering.

Kentucky Gov. Andy Beshear confirmed the first case in Lexington and declared a state of emergency. There have been 10 tests, with nine coming back negative, he said in a press conference. Beshear gave no details about the sick person, except that he or she was in a medical facility. Kentucky repurposed the poison control hotline for COVID-19 calls  (800-222-1222).

Hawaii also confirmed its first case. The patient was likely exposed while aboard the Grand Princess cruise ship, with the Hawaii Department of Health saying it doesn’t think the patient came into close contact with anyone who was ill. There’s so far no evidence of community spread in Hawaii.

Kansas was investigating two potential cases. The Kansas Department of Health and Environment said 11 people previously been tested for COVID-19 but received negative results.

Passengers stranded on Grand Princess cruise More than 2,000 passengers remain stranded onboard a cruise ship off the coast of Northern California, CNET sister site CBS San Francisco reported. Pence said 46 people were swabbed, with 21 testing positive for the coronavirus — 19 crew members and two passengers. The ship was banned from docking in San Francisco but would be brought into a “noncommercial port” where all passengers and crew would be tested for the coronavirus, Pence said at a press conference.

The ship’s previous voyage from San Francisco to Mexico Feb. 11-21 so far resulted in one death and five diagnoses. Former passenger Margie Hartle told CBS that passengers weren’t tested before getting off the ship and that many were coughing during the bus ride back to Sacramento. “We were ground zero and you have 2,500 people walking out right now in Sacramento, up in the foothills, whatever, that might be carriers,” she said. 

March 5: Tennessee Gov. Bill Lee announced the first case of COVID-19 in Williamson County. A 44-year-old man tested positive on Wednesday and was quarantined at home. He had returned from Boston on a nonstop flight before falling ill, according to a report.

Maryland Gov. Larry Hogan said three people in the state have tested positive for the coronavirus. All three cases were in Montgomery County, and the patients were in quarantine at their homes. All three people, a couple in their 70s and an unrelated woman in her 50s, contracted the virus during overseas travel. Hogan declared a state of emergency to ramp up the state’s response. 

Google, Microsoft, Amazon tell some employees to work from home Some companies with offices in Seattle were telling employees to work from home when possible. A Google spokesperson confirmed the move after talking with local health officials. Microsoft published a post Wednesday saying that all Puget Sound and San Francisco Bay Area employees who can work from home should do so through March 25. New York Gov. Cuomo said the state is increasing its coronavirus testing capacity after approval to partner with more labs. Starbucks won’t let you fill your own cup anymore due to virus-spreading concerns, but it will continue to honor the 10-cent discount for those who do bring in their own cups.

San Francisco confirms two cases of unknown origin Mayor London Breed of San Francisco has confirmed two “community-spread” cases of COVID-19 in the city, meaning the patients weren’t known to have traveled or had contact with an infected person. During a press conference, Breed said a man in his 90s with an underlying health condition was in serious condition, and a woman in her 40s was in fair condition. The patients were unrelated and were being cared for in isolation at separate hospitals in the city.

Pelosi signs $8.5 billion emergency response package House Speaker Nancy Pelosi signed a bipartisan US emergency response package, which covers issues across employment insurance, food, telehealth, small businesses and schooling. It’ll help states and local governments with the costs they incur, and also help fund vaccine research. It was headed to President Trump’s desk for final signature.

IBM’s supercomputer is on the case IBM’s Summit supercomputer, one of the most powerful in the world, was joining the fight against COVID-19. Simulations can examine the virus faster than growing the microorganism in labs, IBM said. Jeremy Smith, governor’s chair at the University of Tennessee and director of the UT/ORNL Center for Molecular Biophysics, said the team was “very hopeful” the findings would help inform studies to find a treatment.

“Using Summit, researchers were able to simulate 8,000 compounds in a matter of days to model which could impact that infection process by binding to the virus’s spike, and have identified 77 small-molecule compounds, such as medications and natural compounds, that have shown the potential to impair COVID-19’s ability to dock with and infect host cells,” IBM said in a blog post, adding that this would’ve taken months on a normal computer.

March 4: One death in California was attributed to COVID-19, while New York City began cracking down on price gouging and Australia reported its second fatality.

Contagion movie rose on iTunes Steven Soderbergh’s decade-old story of how humans might respond to a deadly airborne virus hit the top 10 rentals.

Apple out of SXSW Apple canceled appearances at SXSW 2020, joining other huge tech brands like Facebook, TikTok, Amazon and Twitter in skipping this year’s festival because of coronavirus concerns. 

First fatality in California, state of emergency declared On Wednesday, Placer County Public Health in Northern California announced the first death in the state. The victim was an elderly adult with underlying health conditions, who tested positive on Tuesday after likely contracting the disease during a Princess Cruise from Feb. 11-21 between San Francisco and Mexico. The patient was put in isolation at Kaiser Permanente Roseville.

“The state is working with federal officials to follow up on contact tracing of individuals that may have been exposed,” California Gov. Newsom said in a statement. “This case demonstrates the need for continued local, state and federal partnership to identify and slow the spread of this virus.” During a press conference in Sacramento, Newsom then declared a state of emergency for California.

Washington also reported its 10th coronavirus death, while the virus was spreading further in New York. President Trump tweeted late Wednesday that Congress had voted to provide $8 billion in funding to help the COVID-19 response.

Pence says 1.5 million more test kits coming During a coronavirus conference, Vice President Pence said 1.5 million test kits were going out that day to hospitals. In addition, every state health lab and university lab could now conduct a coronavirus test. The goal was to get to a place where all doctors and clinics have access to tests, which he said would be possible “within a number of weeks.”

Second Australian fatality reported in Sydney A second COVID-19 death was confirmed in Australia. A 95-year-old resident of the Dorothy Henderson Lodge at Macquarie Park, an aged care facility just north of Sydney, was diagnosed with the coronavirus after dying. The first Australian coronavirus fatality occurred March 1 in Western Australia after a 78-year-old man returned from the Diamond Princess cruise ship.

The number of cases had risen to 22 in New South Wales, the state’s department of health said. The new cases included an female resident in her 70s at the same Macquarie Park facility; a female doctor from Liverpool Hospital; a female in her 30s from the Northern Beaches; a man in his 50s from Cronulla; and a woman in her 60s believed to have returned from the Philippines on March 3.

New York City to fine stores that jack up prices on supplies New York City tweeted it would begin issuing fines “to any store found price gouging supplies.” (Residents can call 311 to report price gouging.) Sen. Ed Markey on Wednesday sent a warning letter to Amazon CEO Jeff Bezos, asking him not to allow price gouging on the online retailer, while Washington Attorney General Bob Ferguson also warned stores against jacking up prices, saying “we are taking formal investigative actions.”

TED Vancouver conference reportedly delayed TED2020 Uncharted, a conference slated to take place April 20-24 in Vancouver, has reportedly been delayed. TED was considering postponing until July or doing “an expanded and ambitious digital experience,” a spokesperson told CNET in an email.

NASA and the US Air Force to reportedly test working from home Due to fears about the spread of the coronavirus, NASA and the US Air Force were set to test teleworking, according to a Politico report that cited a NASA spokesperson and an Air Force memo. The US Air Force said it’s required to test its telework capacity once a year, which it typically does during snow days. NASA said it’s “taking various actions” to be prepared for the spread of the coronavirus, including making Friday an agencywide work-from-home day. 

March 3: Two deaths in the Seattle area in the week beginning Feb. 24 were attributed to COVID-19, state health officials revealed, according to The New York Times. That brought the death toll in Washington state to nine. Seven new cases were announced in the state, bringing the total number of infections to 21. 

More SXSW cancellations After Facebook and Twitter pulled out of the SXSW festival in Texas on March 2, another social media platform followed suit: the short form video giant, TikTok.

In an emailed statement, the company said: “TikTok has decided not to participate in SXSW this year. While we think the risk is relatively low, we are erring on the side of caution as we prioritize safety for our team, creators, partners, artists, and brands. We are looking at a variety of alternative ways to bring parts of the previously scheduled experience to audiences in creative new forms.”

Tokyo 2020 in doubt Japan Olympic minister Seiko Hashimoto suggested the 2020 Tokyo Olympics could be postponed. 

“The IOC has the right to cancel the games only if they are not held during 2020,” Hashimoto reportedly told parliament. “This can be interpreted to mean the games can be postponed as long as they are held during the calendar year.”  

The International Olympic Committee has doubled down on efforts to ensure the games go ahead as planned. The opening ceremony is scheduled for July 24. The Paralympics are scheduled to run from Aug. 25. 

Google cancels I/O The biggest event on search giant Google’s calendar each year is I/O, a developers conference held in the San Francisco Bay Area. The I/O 2020 conference was scheduled to begin May 12, but Google has decided not to go ahead with the conference this year. Attendees will get a full refund, the company said in an email. 

“Due to concerns around the coronavirus (COVID-19), and in accordance with health guidance from the CDC, WHO, and other health authorities, we have decided to cancel the physical Google I/O event at Shoreline Amphitheater,” Google said in a statement. 

March 2: Confirmation of another four deaths in the US, all in Washington state.

German automaker BMW placed 150 employees under at-home quarantine, according to a report by Automotive News Europe. Germany at that point had reported around 160 cases of the disease.

SXSW sees two big names drop out Twitter announced it’s pulling out of SXSW, citing coronavirus concerns. A blog post from Twitter noted that the company is adjusting its travel policy. “On February 29, we informed our people and started notifying partners that we are suspending all non-critical business travel and events,” the blog post said.

Twitter’s attendance would have included a keynote address from CEO Jack Dorsey, as well as a larger presence from the company. In past years, Twitter has hosted speakers and events at its “Twitter House.”

Facebook announced it’s pulling out of SXSW due to fears over the COVID-19 outbreak.

Google Cloud, a platform that runs a suite of services on the search giant’s cloud, made its biggest event of the year, Google Cloud Next, digital-only. Scheduled for April in San Francisco, the event would now take place digitally, with “streamed keynotes, breakout sessions, interactive learning and digital “ask an expert” sessions with Google teams,” according to a blog post.

Coronavirus virus gets an official name: SARS-CoV-2 A paper, published in the journal Nature Microbiology by the Coronaviridae Study Group, officially designated the coronavirus that causes the disease “SARS-CoV-2.” In a slightly confusing move, the authors suggest it should be considered distinct from the virus that caused the SARS outbreak in 2002 and 2003 — but the virus is closely related to the coronavirus responsible for that outbreak.

The latest data shows that over half of all patients have recovered, with a total of 45,605 COVID-19 cases resolved. It’s unclear whether recovered individuals can be infected a second time.

March 1: A second US death was confirmed in Washington state, in the same facility as the first fatality. New York state confirms its first positive case.

In France, the Louvre, the world’s largest art museum, closed, as a secondary outbreak in Italy continued to spread through the northern region. Around 9.6 million people visited the museum in 2019. 

Feb. 29: The first fatality in the US from the coronavirus was confirmed by the Washington State Department of Health. The man was in his 50s with an underlying health condition, state health officials said. 

Washington Gov. Jay Inslee said Saturday that the state was working to keep its citizens safe, and he declared a state of emergency.

US Surgeon General Jerome Adams tweeted advice for the public to stop buying face masks, suggesting they’re not effective at preventing transmission. This echoed advice from the CDC, which “does not recommend” healthy people wear a face mask to protect themselves from any respiratory disease.

Feb. 28: The Game Developers Conference, a huge gathering of video game developers that takes place in San Francisco every year, was postponed. The event was scheduled to take place March 16-20 but big-name developers like Epic, Facebook/Oculus, Blizzard and Microsoft more decided to pull out.

“After close consultation with our partners in the game development industry and community around the world, we’ve made the difficult decision to postpone the Game Developers Conference this March,” the organizers said in a statement. “Having spent the past year preparing for the show with our advisory boards, speakers, exhibitors, and event partners, we’re genuinely upset and disappointed not to be able to host you at this time.”

The GDC didn’t provide a new date for the event, saying only that “we fully intend to host a GDC event later in the summer.” 

Feb. 27: Coronavirus concerns prompted cancellation of Facebook’s F8 developers conference, the biggest event for the social media giant. The event was scheduled for May 5-6.

“This was a tough call to make — F8 is an incredibly important event for Facebook and it’s one of our favorite ways to celebrate all of you from around the world — but we need to prioritize the health and safety of our developer partners, employees and everyone who helps put F8 on,” Konstantinos Papamiltiadis, Facebook’s director of developer platforms and programs, said in a statement.

Instead of F8, Facebook said it’s planning to bring developers together through locally hosted events, videos and livestreamed content.

Feb. 26: In a press conference, President Trump said the risk to Americans remains low. “The No. 1 priority from our standpoint is the health and safety of the American people,” he said. He noted that of the original 15 US cases, one remained in hospital and was “pretty sick,” with 14 others either fully recovered or in recovery. He also announced that Vice President Pence would coordinate the response to the virus.

The CDC confirmed local transmission of the virus had occurred in the US. This means the virus was able to spread from person-to-person in the US, rather than being imported by a traveler.

Feb. 25: A top Olympics official suggested the 2020 Tokyo Olympic games, scheduled to begin July 24, could be canceled, with a decision to be made by the end of May. 

Feb. 23: A number of high-profile events were canceled in Italy, including Serie A football matches and one of the world’s biggest fashion shows in Milan. The Venice Carnival, a world-famous masquerade, was also cut short. Tens of thousands of Italians were put into lockdown after a third death was recorded in the country.

Feb. 21: Italy reported the first person-to-person transmission of the virus and the total number of COVID-19 infections had risen to six. The cases were clustered in Italy’s Lombardy region, in the north. A day later, Feb. 22, Italy reported its first two deaths.

Feb. 20: South Korea reported its first death from the coronavirus.

Feb. 19: Iran’s first confirmed cases of COVID-19 were reported and, on the same day, its first two deaths.

One of the biggest video game conferences, PAX East, which takes place in Boston, saw a few cancellations. Sony, which manufactures the PlayStation and was scheduled to show off the highly anticipated title The Last of Us Part II, decided not to attend because of coronavirus concerns.

In a breakthrough, researchers working with the coronavirus created the first 3D map of a special protein that allows the coronavirus to get into human cells. Using state-of-the-art microscopy, the team at the University of Texas at Austin showed the virus is able to bind to human cells stronger than the SARS coronavirus but also noted the spike proteins can be targeted in the creation of a vaccine or treatment.

A vaccine, however, is still at least 18 months away. 

Feb. 17: Apple announced that the coronavirus outbreak would likely hurt its first-quarter revenue as factories were shuttered and fewer Chinese customers were purchasing iPhones.

“Work is starting to resume around the country, but we are experiencing a slower return to normal conditions than we had anticipated,” Apple said in a statement. “As a result, we do not expect to meet the revenue guidance we provided for the March quarter.”

Shigeru Omi, the chief director of the Japan Community Health Care Organization, suggested the Olympics could be disrupted or even canceled, depending on how the virus continues to spread and evolve over the next few months.

“Whether the virus is under control by the time of the Olympics is anyone’s guess,” he said.

Feb. 14: The US National Institute of Allergy and Infectious Diseases released new images of the virus for the first time. NIAID’s Rocky Mountain Laboratories in Montana used specialized equipment, scanning and transmission electron microscopes, to capture the digitally colorized close-ups.

Feb. 12: Mobile World Congress, the world’s largest trade show for the mobile industry, was canceled by the show’s organizer, the GSMA. The cancellation came after numerous big names including LG, Nvidia, Nokia, Vodafone, Amazon and Facebook announced they would be pulling out.

Chinese health authorities reported a jump in the number of cases and deaths in Hubei, the epicenter of the outbreak. Over 13,300 new cases were recorded in Hubei alone, an increase of 700% over the previous day. Chinese authorities had adopted a new clinical method for confirming cases, which saw them add “clinically diagnosed cases” to the count, potentially helping patients receive treatment sooner, according to CNN.

Feb. 11: The WHO officially named the disease caused by the novel coronavirus “COVID-19” (for coronavirus disease 2019.) That made things a little confusing, because the virus itself is not named COVID-19, but SARS-CoV-2.

Feb. 9: The outbreak reached a grim milestone: 811 deaths — more than the 2002-2003 SARS epidemic, which killed around 800 people.

Feb. 8: The first US citizen died from COVID-19 in Wuhan.

Feb. 7: Li Wenliang, the Chinese doctor who originally sounded the alarm about a spate of mysterious SARS-like illnesses in his WeChat group, died. He was 34.

Feb. 4: The Diamond Princess returned to port but Japanese health authorities were invited onboard to check the crew for signs of the coronavirus. It had 2,666 guests and 1,045 crew on board.

Feb. 2: The first death outside China was reported in the Philippines. A 44-year-old man from Wuhan with preexisting health conditions developed severe pneumonia and died at a hospital in Manila.

Feb. 1: A passenger who stayed aboard the Diamond Princess cruise from Yokohama, Japan, and disembarked in Hong Kong was confirmed to have the coronavirus. The ship was scheduled to return to port Feb. 4.

Jan. 30: The WHO declared a public health emergency of international concern. Tedros Adhanom Ghebreyesus, the director general of the WHO, said the organization was working with national and international public health partners to get the outbreak under control. It also issued recommendations to prevent the spread of the virus and ensure a “measured and evidence-based response.”

Jan. 28: 100 deaths were recorded in China, with most of them coming from Hubei province, the epicenter of the outbreak.

Jan. 24: Major attractions began closing down, including Disney Parks in Shanghai and Hong Kong. 

Jan. 23: China began to lock down cities including Wuhan, the epicenter of the outbreak. Public transport was suspended, as were flights and trains out of the city.  The travel restrictions were extended to four other cities (Huanggang, Ezhou, Chibi and Zhijiang) later that day, and constraints were announced in eight more cities on Jan. 24. Beijing canceled Lunar New Year plans, which were to begin Jan. 25.

Jan. 20: The first human-to-human transmission was reported by a Chinese expert on infectious diseases after two individuals caught the disease from family members and 14 health workers were infected by patients. This was a significant development in the spread of the virus and suggested cases could be much higher.

Jan. 16: Japan saw its first case of the virus, a man who had traveled to Wuhan.

Jan. 13: The first case outside China was reported by the WHO. A woman who had traveled from Wuhan to Thailand tested positive for the novel coronavirus.

Jan. 11: The first death was reported. A 61-year-old male with an underlying health condition who had visited the seafood market died from heart failure on Jan. 9.

Jan. 10: The genetic sequence of the isolated coronavirus was shared for the first time. In total, four sequences of the virus were shared by various Chinese research institutes. A team investigating the virus eventually published their research in the New England Journal of Medicine on Jan. 24.

Jan. 7: A novel coronavirus was identified from patients and given a placeholder name: 2019-nCoV. 

Jan. 1: China shut down the Huanan Wholesale Seafood Market in Wuhan, which was linked to a number of patients with the disease.

2019

Dec. 31: China alerted the WHO of a spate of illnesses in Wuhan, China. The central city lies some 650 miles south of Beijing and is home to more than 11 million people.

Dec. 30: Dr. Li Wenliang, a doctor at Wuhan Central Hospital, warned colleagues from his medical school via WeChat about a cluster of patients being treated for viral pneumonia, linking it to the SARS coronavirus. Investigations would later rule out that virus, which had caused an outbreak in 2002-2003.

Wenliang was reprimanded by Chinese authorities for speaking out about the mysterious illnesses he had seen at his hospital and was forced to sign a statement saying he was spreading rumors.

Dec. 1: The first patient experienced symptoms of the mysterious pneumonia-like illness now known as COVID-19. No epidemiological link was established between this case and later instances of the disease.

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[immedtech]

FDA warns hospitals about security flaws in some GE medical equipment

Some GE medical equipment have vulnerabilities that make them easy to tamper with, according to the FDA. The agency has warned hospitals and healthcare providers that a third-party cybersecurity firm has identified flaws in certain GE Healthcare Clinical Information Central Stations and Telemetry Server models. Hospitals use these devices to monitor patients' information, including their temperature, heartbeat and blood pressure, and are usually located in the nurse's bay or other central locations within a facility.

Those vulnerabilities, the FDA said, could allow bad actors to remotely take control of the devices in order to generate false alarms or silence real ones. An attacker could, for instance, stop the system from notifying providers about a patient's cardiac status, putting their life in danger. Thankfully, the FDA has yet to receive reports of patient harm or device malfunction involving GE's central stations. The company has taken steps to prevent them all the same, advising customers to separate the equipment from wider hospital network and instructing them on where they can get a patch when it becomes available.

The FDA has been keeping a close eye on medical equipment cybersecurity measures and issues over the past years. It issued a final guidance instructing manufacturers to boost pacemakers' and insulin pumps' protections against cyberattacks in 2016. The agency also previously issued a warning about certain pacemakers that are vulnerable to hacking and even recalled half a million pacemakers due to hacking fears.

Via: CNBC

Source: FDA

- Repost from: engadget Post

#ITlive #engadget #FDA warns hospitals about security flaws in some GE medical equipment

[conveyancings-blog]

Clinical Trial Budgeting and Technological Impact

The current clinical trial and drug regulatory process have lagged behind advances in scientific research. Regulatory approval is based on the evidence of efficacy and safety gathered from pivotal trials. Most experts agreed that traditional approach to drug development constitute a blunt tool where a more focused experiment could suffice instead of a one-size-fits-all approach which is ineffective and wasteful.

According to studies conducted by New England Journal of medicine, almost nine in ten clinical trials do not meet FDA requirement and thus do not reach the market. Project fails when they do not meet endpoints. Lack of efficacy and complex protocol are the major cause of failure. To reverse this trend, productivity must be directed towards the poor predictive capability of the current experimental model.

Clinic trial plays a major role in drug development and advancement in technologies such as drug positioning, therapeutic target, and drug efficacy prediction are helping researchers and pharmaceutical companies in drug development.

Traditional trials have fixed parameter that is determined in advance and remain constant throughout out the process. One promising approach to modernizing clinical trials and maximizing efficiency is by adaptive trials which allow for certain parameters such as sample size and treatment regimen to be modified or replace on interim results.

The major hurdle is that investment in clinical research is dwindling as government and stakeholders tightened their budgets. As major sponsors revenue stabilize and cost continue to rise, the clinical trial finds itself in a financial squeeze. Pharmaceutical and medical-device companies have been intent on trimming budgets. Lean contract negotiations are the norm these days, no sponsor is walking around with money burning hole in their budget and most are responding to mandate to save cost by requiring CROs to provide unrealistic competitive budgets which are disastrous. With tightened budget, short-sightedness has become the order of the day and as a result, both sponsors and CROs reputation suffered.

Cutting back drastically or unwillingness to adequately fund a project will produce a poor result. This simplistic strategy is unrealistic and unsustainable. It is important to note that focusing solely on short-term strategy will be detrimental in the long-term. If sustainable research climate is created, prosperity will definitely grow.

There has been increasing effort in utilizing technologies to streamline protocol and boost efficacy in clinical research. The use of technology is empowering research professionals by helping them to make a decision based on resulting data. With the aid of technology, organizations are reducing cost and speeding up evaluation process. Technology allows for accrual of data faster and that information can be disseminated in real time. This can lead to a better decision being made on protocol, patient recruitment, and trial sites.

Here is the list of technologies impacting clinical trials today

Risk Based Monitoring (RMB)

Companies use risk based monitoring to target and prioritize resources, identify risks relating to quality, safety of subjects and integrity of clinical trial data. Risk based monitoring (RMB) can incorporate targeted monitoring or triggered monitoring and reduced source document verification (SDV).

Traditionally, source data verification (SDV) were conducted 100% via on-site monitoring, a labor intensive approach. Reduced SDV limits the measure of SDV at the site, study and subject level.

The quest for more key ways to manage clinical trials has distinguished risk based monitoring which attempts to manage resources without compromising on clinical quality. The variables of protocol compliance, data integrity, and patient safety etc. impact how assets are deployed.

The impact of technology in risk based monitoring is profound and currently in markets are clinical trial management systems (CTMS) and remote data capture (RDC) which can support risk based monitoring system. Some systems still support manual entering and reporting of clinical trial data, for this reason, there is a need to setup more robust systems for flagging and alerting data automatically, these alerts can be developed for notifying those who need to act when an issue arises.

According to Medidata, the cost of onsite monitoring is approximated at 28.7% of study budget and project management at 26.47%. In moving to RMB, monitors can spend their time more judiciously and reduce cost.

Electronic Trial Master File

In biopharma industry, every organization involved in clinical trial maintains a trial master file containing several thousand pages of regulatory documents needed for each clinical trial.

Using a paper-based or hybrid trial master file system to manage thousands of clinical documents, processes and tasks can be overwhelming and can cause errors or misread that can ruin clinical trial and put it at risk for noncompliance.

Organizations usually employed an Enterprise Content Management System (ECM) to manage clinical trial regulatory documents. The ECM based eTMF offers automated methods to index, archive, and report on documents and content.

To eliminate paper from a clinical trial study, electronic signing utilizing digital signatures from verified users is being employed. Globally, most countries including the US and many countries in EU are accepting digital signatures in place of wet signatures thereby eliminating the need for scanned documents.

An electronic trial master file (eTMF) offers a robust platform to document management which allows study team members to gain a quick insight necessary to efficiently manage clinical trials and speedup time to market. Electronic document management processes are being adopted at a steady pace as it becomes vital to business productivity, shortened biopharma product development timelines, and cost cutting.

eSource

In 2013, the FDA release its Guidance Document on Electronic Source Data in Clinical Investigations, since then sponsors and study sites have been adopting and employing eSource as a method of recording data in clinical trials.

The definition of electronic source (eSource) is a clear concept -- to capture or process source data electronically, this data exclude the source data that was captured on paper and transcribed into an electronic database. In eSource, the source data element itself must be electronic.

The benefit of eSource is apparent and the FDA endorsed it because it will be useful in: facilitating real-time entering of electronic source data during subject visits, removes the need to duplicate data, allows for accuracy and completeness of data by using electronic prompts for inconsistent and missing data and lessens the chance for transcription errors.

The need to modernize and streamline the way data is collected are evolving, as a result, much of the exploratory done thus far by several pharmaceutical companies have been mostly to build internal competency. In moving forward, it is critical that standards and interoperability within different eSource modalities come together to help create systems that provide accurate data in clinical research.

Using Clinical Data Repository (CDR) to drive optimization

The ability to effective manage, report and analyze data is of paramount importance in clinical trials. The major hurdle is that data from clinical trials are frequently entered by clinicians electronically or manually across multiple channels including EDC, LIMS, CDMS and IVRS and other systems each with unique underpinning needs. This approach causes data to end up in different databases making it complex and time-consuming to leverage and synchronize the data.

There is confusion as to what constitute or defines CDR as distinct from a clinical data warehouse (CDW). CDR can be thought of as consolidated storage and transfer of data for clinical trials including security, workflow, and systems for performing daily task all under one umbrella.

Centralization of the storage and management of data results are the purpose of CDR and to provide a steadfast and reliable infrastructure that supports clinical data analysis and management, facilitate standardization and secure transfer of data, allow for analytics and cross-trial analysis and to leverage data from trials across the pipeline.

In conclusion, progress in clinical trials and development has been the backdrop to scientific success. While new technology is helping streamline protocol and save cost, the future also requires savvy integration by linking data collected in trials with data generated in the clinical treatment phase, study goals should be aligned with protocol to eliminate activities that do not support endpoints.

[dichoticwomanism]

Reflexion Health and Visiting Nurse Service of New York Bring Virtual Rehabilitation <b>Therapy</b> to ...

VERA™, Reflexion Health's lead product, is an FDA-cleared Virtual Exercise Rehabilitation Assistant that is able to support and remotely monitor physical therapy exercises in real-time. VERA brings the guidance of a physical therapist into the home to coach, motivate and assess exercise movements ... from Google Alert - Physical Therapist http://ift.tt/2F7mrQC

#IFTTT #Google Alert - Physical Therapist

[flipfundingstuff]

The Top 10 Offline Industries Seizing Online Opportunities

Scan the business landscape and you’ll be hard-pressed to find an industry unaffected by the COVID-19 pandemic. Social distancing rules, safety concerns, and increasing costs have businesses scrambling to accommodate customers. Many industries that traditionally clung to analog processes have been forced to turn to digital options to survive and thrive.

Here are 10 of the top traditionally-offline industries finding success in pivoting to online formats:

1. Education

Educational institutions stumbled through distance learning at the start of the pandemic. Most have started the 2020-2021 school year offering a combination of virtual-only, in-person, and hybrid classes. Time will tell if the seesaw tips more toward remote learning—the University of North Carolina at Chapel Hill, for example, began with in-person classes but within 1 week reverted to online-only learning due to COVID-19 outbreaks.

While there are pros and cons to distance learning, it’s here to stay in some form as the traditional education model shifts. Students who succeed with remote learning will expect more of the same in the future and may push for educational options that offer intercollegiate course offerings. Schools facing severe budget cuts may find that distance learning reduces the money needed to maintain physical classrooms.

2. Entertainment

Pandemic closures forced changes across the entertainment industry—especially for those whose business model depended on the physical presence of fans being physically present.

With movie theaters closed, the film industry delayed the release dates for some films while releasing other films, including Disney’s Mulan, on direct-to-digital channels. Behind the scenes, the entire process of film production is now viewed through a “what can be done remotely” lens, as crews face challenges with traveling to sets, shooting crowds or close-contact scenes, and collaborating on scene edits.

Small-time bands like Scythian that used to sell out smaller venues have turned to online streaming and virtual tip-jars. Even high-profile musicians like Tim McGraw have sold tickets to online streaming concerts. In the long term, there may be a hybrid approach to concert tours—most artists and fans want the energy and noise of a concert, but some fans may be willing to pay a premium for a physically-distanced experience.

3. Events and Conferences

Events and conferences, including large ones like the IBMA World of Bluegrass Conference and the Democratic National Convention, have transitioned to online offerings.

Virtual conferences have many benefits, including lower costs and wider audience reach. With a broader participant pool (geography and time zones are irrelevant) and overall reduced costs (no need to pay for event space or chair rentals), small business owners may wish to capitalize on this market.

Even smaller events such as annual meetings or local networking groups are turning to online options. That monthly meetup of professionals at your local coworking space has converted to live streaming and a bring-your-own-snack mentality.

4. Financial Services

When physical bank branches closed, their digital offerings (or lack thereof) took center stage. Customers embraced digital and mobile options. Banks, traditionally slow to change, found that manual processes like loan approvals wouldn’t work in the online world.

And small business owners seeking PPP loans often discovered that their local banks couldn’t help them—either the bank did not offer PPP loans or they’d already earmarked their favorite customers for approval. Online lending marketplaces like Lendio stepped in to provide options outside of small business owners’ geographical areas.

5. Fitness

With gyms shuttered, consumers turned to online fitness options. According to McKinsey, the “US online fitness market has seen approximately 50% growth in its consumer base since February 2020.”

Yoga studios have changed in-person classes to live-streaming sessions. Personal trainers have created workout schedules for their clients to do at home and, for an additional fee, offered virtual coaching via Skype. Even major races like the New York City Marathon have converted to virtual options.

6. Healthcare

Due to the pandemic, the use of telehealth has skyrocketed. Private practices that previously may have considered adopting telehealth jumped on the bandwagon to protect their staff and patients. Modifications to government regulations, including changes to HIPAA and Medicare rules, have allowed telehealth to be more widely adopted.

Other pieces of the healthcare puzzle are evolving to include online options, too. Wearable devices provide remote monitoring and reporting of vital signs. Social listening apps identify virus breakouts, and AI software (via chatbots) provides first-level triage to free up doctors’ time.

Telehealth isn’t just for humans—many veterinarians began offering it once the FDA modified regulations that had required in-person animal exams.

7. Real Estate

Traditionally, potential buyers want to walk through a prospective new home to plan where their loveseat will fit. Photos and, occasionally, videos were available online to allow a buyer to rule out properties from the comfort of their own couch, but in-person tours were the overall norm.

When COVID-19 safety concerns hit, the desire for digital home-buying tours exploded. Even though most states classified real estate services as essential, buyers and sellers alike wanted online viewing options. Some agents provided an alternate version of a digital tour by opening a FaceTime session with the buyer and following “show me this next” directions. Digital tours, according to a University of Iowa study, often result in a house selling for 2–3% more than a house without an online tour.

8. Religious Organizations

Religious organizations pivoted to offer services via online broadcasts. Similar to how healthcare laws shifted to permit telehealth service, some religious rules had to be altered as well. For example, Jewish law requires 10 adults to be in the same physical space to allow for public prayer, but the Rabbinical Assembly has provided guidance for virtual equivalents during the pandemic.

Faith-based organizations may find value in keeping some of their online offerings post-pandemic. Carey Nieuwhof, a pastor, author, and public speaker, suggests that digital content allows churches to engage more people. For example, a teenager may listen to a short podcast versus attending an early morning session. And an online sermon could expand a church’s member list to include church-surfers—people looking for inspiration from multiple sources.

9. Restaurants

Digital options became a lifeline for restaurants during the pandemic. With dine-in services closed for months, restaurants have focused on technology to survive.  Electronic menus have reduced the burden of making regular changes to accommodate supplier issues or offer new items like family-size meals. Contactless payment systems have helped to reduce touchpoints. Online ordering is now a must—and even when it’s safe to fully reopen, many customers will want to continue the convenience of carry-out.

Delivery apps like Uber Eats and Grubhub and alternative local delivery services have stepped up their game to entice restaurants to use their service for delivering to-go meals.

10. Retail

Without a doubt, the pandemic has altered the retail landscape. When stores closed, consumers flocked to online buying. Many shoppers have continued with their new behaviors, like using buy online, pick-up in store (BOPIS) or home delivery, even as brick-and-mortar stores reopen.

In-person retailers that implemented online stores altered offline services to fit their online equivalents. For example, bookstores switched in-store author readings to online storytimes instead. In the clothing industry, digital concierges have replaced the sales associate who brought new items to the fitting room.

Converting any business to include online offerings takes time and money to purchase equipment, retrain employees, and implement process changes. The need or desire for in-person services won’t completely disappear, but most industries can reduce costs or expand their market by going digital.

The post The Top 10 Offline Industries Seizing Online Opportunities appeared first on Lendio.

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[dipulb3]

Coronavirus test used by White House has questionable accuracy

New Post has been published on https://appradab.com/coronavirus-test-used-by-white-house-has-questionable-accuracy/

Coronavirus test used by White House has questionable accuracy

The federal government also continues to distribute thousands of the rapid coronavirus tests made by Abbott Laboratories each week throughout the country, spending what adds up to hundreds of millions of dollars on them, all while questions about the test’s accuracy have mounted and some states are urging precautions for health care providers using them.

Abbott’s point-of-care “ID NOW COVID-19” test, which was promoted by Trump at the White House, produces results in minutes rather than hours and is portable enough to be used in mobile testing sites and rural regions that lack easy access to labs.

Yet studies have raised doubts about the Abbott device’s accuracy. Abbott has disputed those findings and pointed to other studies with more favorable results, but a spokesperson for the FDA told Appradab on Wednesday that the agency has received a total of 126 reports of “adverse events” about the ID NOW test. There are three other point-of-care tests authorized by the FDA, but the agency has not received any adverse event reports for those, the FDA spokesperson said.

In May, the FDA announced “possible accuracy concerns” with the device and said it had received 15 adverse event reports. The FDA this week did not specify the contents of all the adverse event reports, but in a statement to Appradab, an Abbott spokesperson said the company has shared reports about false negatives with the FDA, meaning instances when tests show patients are not infected with Covid-19 when they are actually positive for the disease. Abbott also said the adverse events it is required to report are a small fraction of the tests that have been performed.

Despite such concerns raised in recent months, an office within the Department of Health and Human Services has signed contracts totaling more than $200 million to purchase Abbott’s rapid test, according to contract data. That includes a $174 million contract signed on June 4 that said the agency “has a requirement to purchase” the tests.

A spokesperson for HHS did not respond to a question about the details of that requirement but said in a statement that HHS, including the FDA, is closely monitoring the efficacy of the ID NOW tests and working with Abbott on follow-up studies.

“We do believe Abbott positive tests are accurate and that the Abbott test remains critically important and accurate when used as directed especially for remote areas and during outbreak investigations. At this time we are not recommending to end the use of Abbott test devices or tests,” the HHS spokesperson said.

An Abbott spokesperson said the test is delivering reliable results, that the company has delivered 4.3 million ID NOW tests to all states and that the rate of false negative complaints is 0.015%.

HHS has been distributing tests for the devices throughout the country since it initially became available, but some states are urging caution.

Ten state health agencies told Appradab they specifically recommend or require that individuals who test negative on the Abbott rapid device be retested, and most recommended using a different, slower, more reliable method for diagnosing Covid-19, known as lab-based “polymerase chain reaction” or PCR tests.

Other states said they have pointed health care providers to the instructions for the ID NOW posted on the FDA’s website, which state that negative results “should be treated as presumptive,” and if patients show signs and symptoms of the virus, they should then be tested with different authorized tests.

Vermont’s commissioner of health, Dr. Mark Levine, decided not to give the Abbott rapid devices received from the federal government to hospitals in the state due to the FDA’s update on possible accuracy concerns, according to a spokesperson for the state’s Health Department.

A Wisconsin Department of Health Services spokesperson told Appradab that the ID NOW tests are used in different locations in the state but that “We have urged caution when using these instruments.”

Other states have found the Abbott tests useful. A spokesperson for the Rhode Island Department of Health, Joseph Wendelken, said the Abbott rapid test has been “enormously beneficial” and has enabled the state to quickly identify thousands of positive cases and get those individuals and their recent contacts into quarantine.

But Wendelken also said the Rhode Island COVID-19 Testing and Validation Task Force reviewed studies on the ID NOW and recommended phasing out the state’s use of it.

He described the test as “a little less sensitive than other tests,” and said, “For that reason, we decided strategically to be less reliant on Abbott ID Now tests as other, more sensitive tests came onto the market.”

Dr. Mark Pandori, director of the Nevada State Public Health Laboratory, which receives ID NOW tests from HHS and disperses them in the state, said that while there has been some concern over the test’s quality, other data show the test performs well.

He said the test must be performed exactly as the manufacturer has instructed, and although such point-of-care tests typically do not perform as well as lab-based tests, he said they serve a purpose.

“The convenience and power of being able to run the test so conveniently is considered against the slightly lower performance factors,” Pandori said.

In April, Abbott warned that its device can produce false negatives if a special solution — known as “viral transport media” — is used to move or store patients’ samples. The company said customers should instead only place swabs with patient samples directly in the device.

The FDA posted its alert about the Abbott test in May after researchers at NYU Langone Health in New York released a study that found the test missed between a third and about half of infectious samples identified as positive by another point-of-care test by the company Cepheid. While the ID NOW delivers results within 13 minutes, the Cepheid test delivers them within 45 minutes.

The authors of the study acknowledged it has limitations, including its small sample size, but said the Abbott test was “unacceptable” for use with their patients.

Abbott has argued that study was “flawed” due to two different sample collection techniques, no tiebreaker test for discrepancies and a population that included patients with low viral levels who were tested more than two weeks after they first developed symptoms. A spokesperson for NYU Langone Health said they stand by the study’s findings.

In a statement, Abbott shared links to other studies that have found higher accuracy rates, and said, “ID NOW is delivering reliable results on the frontlines of this pandemic with accuracy rates in some studies as high as 94.7%”

But additional studies have found differing results. An evaluation from Northwell Health, for example, found that the Abbott rapid test missed 12.3% of positive cases. Research from Columbia University Irving Medical Center concluded that the ID NOW correctly identified only 73.9% of infectious samples compared with another test.

Scott Becker, the CEO of the Association of Public Health Laboratories, which represents state and local public labs, said he is waiting for additional guidance from the FDA on the ID NOW to better understand the test’s performance.

Becker said that in light of the emergency of coronavirus, he thinks HHS did the responsible thing by procuring a point-of-care diagnostic for states that had been authorized by the FDA, but he said emerging data must be considered in future decision-making.

“Until we get the results of new information from FDA and Abbott, I think there will be this dichotomy,” Becker said, referring to differing assessments and approaches to using the test. “Right now, we need all the tools that we can get our hands on, but they have to be tools that work.”

[technicaldr]

Why Healthcare Needs the Internet of Things

What is The Internet of Things?

The Internet of Things refers to smart devices that can collect and transmit data to a remote server, perform functions without any human intervention or automate tasks using voice commands. IoT devices are used everywhere, from smart homes and cars to games and business applications.

  More healthcare organizations are beginning to adopt IoT technology into their day-to-day operations to improve the efficiency of the services they provide. However, healthcare’s initial investment in IoT is a small drop in a large pond.

Why is IoT Important in Healthcare?

Healthcare can be improved by steeping itself in technology. Currently, IoT is used for things like smart sensors, remote monitoring of patients, activity trackers, biometric sensors, medication dispensers, intelligent beds, glucose monitors, and medical device integration. A large percentage (64%) of the equipment used in healthcare that is connected to the internet and cloud services are patient monitoring devices.

Medical wearables can monitor things like blood pressure, oxygen levels, blood sugar levels, heartbeat, weight, and ECGs. Tech gurus are advancing the capabilities of these devices all the time.

Safety of Family Doctors

The more that healthcare plunges into technology, the less place there is to hide. The internet is a very transparent venue with everything out in the open. Part of improving the quality of care is being able to rely on the standards of the right healthcare providers. Some of the ways that patients can use technology right now to ensure they get the best care are:

●      Check public records to look for any red flags such as malpractice lawsuits, DUIs, arrests, or any other indicators that perhaps it’s time to look elsewhere.

●      Check doctor review online. There are dedicated websites where patients can review surgeons, family physicians, and other types of specialty medical personnel.

●      Perform a Google search before starting to use a particular doctor and see what comes up.

Revolutionizing the Treatment and Diagnosis of Disease

There is hardly anything more important than good health. Should the healthcare industry fully commit to this technology, the benefits are unlimited. Patients and doctors would be connected in ways that we cannot currently conceive.

  One example might be shared calendars to coordinate visits and check-ups. Automatic alerts when something with the patient’s health changes. The patient’s chart would be saved in the cloud and linked to their wearable device, thus allowing the doctor immediate access to files and a much faster response time to diagnose and respond to illness. This level of connectivity would revolutionize the doctor’s ability to dispense treatment options.

  It’s not that hard to imagine that monitoring devices could become smarter. Instead of just alerting the doctor, it would take action such as dispensing critical medicine or raising or lowering body temperature to save the patient’s life before the doctor even gets there. In 2017, the FDA approved the first digital pill that patients swallow. It then feeds data back to a wearable device on the user’s wrist.

  The digital pill’s intended use is to monitor dosage amounts for prescription medicine. However, the possibilities for this are endless.

Benefits of IoT

Some of the vast benefits of IoT integration into healthcare are as follows:

Information is power. The data collected by millions of connected devices could potentially allow AI simulations to come up with solutions in a fraction of the time it takes now to develop vaccinations, cure illness, and solve other healthcare challenges. There are many long-term benefits, including disease management and potential cures, through data collection and analysis.

Chronic illness monitoring. Patients who require regular ongoing monitoring and care would benefit significantly from this type of connectivity. Diabetes patients can wear glucose monitoring wearables so their doctor can see their levels at any time of night or day. Additionally, heart patients could use smart pacemakers that send alerts if their heartbeat shows signs of arrhythmia or other abnormalities. IoT could save a lot of lives.

Improving patient care and doctor response time.  Wearable monitoring devices allow real-time evaluation and much shorter response times. These same devices can help in preventative care if say a patient’s cholesterol or glucose levels start to rise; the doctor can contact them immediately to provide guidance for change.

Telehealth and telemedicine. In rural areas, telemedicine and telehealth are widely used because medical facilities are far away. Video chat and connections through other IoT devices promote better relationships between patients and medical staff while increasing patient satisfaction.

IoT monitoring. Hospitals that use IoT to monitor equipment save in replacement costs and downtime. Monitoring systems alert admins when something requires maintenance, saving money, and potential liability if something were to go wrong.

Patient records.  Consolidating patient records into one file stored in the cloud would revolutionize access by any number of specialists who needed to review the patient’s chart. It would also help to eliminate errors, omissions, misdiagnosis, and help to avoid allergic reactions to medications. On the patient side of things, they would fill out one form, and that single record would follow them everywhere throughout their entire medical history—no need for more forms or unnecessary paperwork.

Staff monitoring and compliance.  Hospitals and medical offices are busy places, and managers don’t always have the time to watch everyone closely. Automating these tasks using technology can save millions in lawsuits and compliance issues.

Technical Dr. Inc.'s insight:

Contact Details :

[email protected] or 877-910-0004 www.technicaldr.com

[toplockny]

The New Normal – Body Temperature Being Detected by Innovative Thermal Imaging

The New Normal – Body Temperature Being Detected by Innovative Thermal Imaging

Things are anything but normal, considering the world is dealing with the same pandemic at the same time. Industries have had to develop creative ways of getting things back to normal for people and businesses despite apprehension. It is inevitable; things have to start operating again if our society is to survive. One government agency seemed to be ahead of the game, The Defense Department. They have used thermal imaging for decades. Today, it is being used as a way to detect COVID-19. Thermal cameras use heat to form an image based on temperature. With the help of the U.S. Army, who led the initiative, businesses began using thermal cameras to reopen. Once they realized that the same equipment that could check the military personnel for elevated body temperatures, they realized that it could be used to also check civilians for elevated body temperatures. These prove a lot more effective than the hand-held thermometers that you may notice people holding as they screen patients and customers. This is because the thermal imaging equipment allows the operator to be at a safe distance from the person being screened. No physical contact is necessary. This means that more people can be screened at a faster pace. Temperature is measured from up to 8 feet away with the use of an infrared sensor that sits on a tripod. This process makes the person who is being screened and the administrator feel safer. Top Lock Locksmiths and Security implements body temperature detection cameras.

Industries Who Rely on Thermal Imaging

Other industries have long used thermal imaging to perform their jobs, such as firefighters. With the aid of the thermal imaging camera, they can see through smoke, which allows them to find fire hot spots so that they can properly aim the water. They can also see which areas should be avoided whenever there is no visibility due to smoke. It can also help them find someone who is trapped in the fire. DOD vehicle mechanics and aircraft mechanics will also use this equipment to identify faulty mechanical and electrical parts without ripping the engine apart. Its normal temperatures are compared with the thermal camera images to figure out if and where the problem may be. The Coast Guard also uses thermal imaging cameras to find terrorists and smugglers who may be hiding near ports and other waterways. The images produce high-quality results regardless of the weather or how dark it is. No doubt if the military and other important government agencies see fit to use the thermal imaging camera, why shouldn’t you.

Thermal Cameras Are the Way of the Future

Thermal cameras are certainly the way of the future and it looks like they are here to stay. They are said to be the fastest-growing segment in security today and are said to be worth millions. Even if the pandemic should end sometime soon, chances are that thermal cameras won’t be going anywhere. With video surveillance camera sales are going down, there is room for something else that is innovative and that is sure to benefit us now on into the future. Those manufacturers who can respond to the demand now, are setting them up for success very shortly. Many manufacturers can see the benefit of the body temperature detection cameras and recognize it as a must-have for the future. If this pandemic should end tomorrow, there is always the chance that another one is just around the corner. Having the equipment in place can help keep things functioning.

Thermal Cameras and the Detection of Fever

Many companies are indeed expressing an interest in a fast and efficient way of screening visitors, contractors, and employees with an elevated temperature, generally above 100.4°F, as they enter their business. They are being looked at as a possible return-to-work solution that keeps everyone safe and allows them to carry on their business as usual. The businesses that have taken the time to learn how the thermal cameras can be of use to them have discovered that they can offer some measure of protection. While they are a welcome sight, they have also created some confusion. Up until now, most businesses haven’t really had a reason to explore thermal imaging.

Only a few FDA-approved thermal cameras and software solutions are in use today. In most cases, they serve a small market but the demand is growing and so are the markets that are using them. The installation of this type of equipment can be expensive but based on the market that it serves; it can offer a significant return on investment. The cost will vary based on the industry it is used in, the environment, and how it is installed. There are some great options for commercial applications that offer scalable and frictionless temperature detection. They help to deter visitors, contractors, and employees who do not feel well from coming into the workplace for fear of being turned away as they are screened. It will enhance the safety of others by preventing transmission of the virus into the workplace and spreading amongst others. The temperature detection equipment can be the start of the development for additional screening and possible removal of sick individuals.

What’s Right for You

In today’s volatile environment, there are so many misconceptions that you may not know what to believe. Some really influential people are trying to capitalize on the current crises by taking advantage of those who are eager to get things back to normal. What may be right for someone else may not be right for you? Regardless of how eager someone might do get things back the way they were, the reality is that things may never get back the way that they were, which is why everyone must be willing to adapt. Any business that is interested in thermal imaging cameras should understand what it does and clearly identify ways that it can be of use to them.  Currently, there is more demand than there are imaging cameras. This gives most people the time needed to perform their due-diligence to determine what might be best suited to their needs, short-term and long-term.

While thermal imaging cameras are extremely useful today, there are other mitigation procedures that a company can consider, such as the use of access control to track the possibility of exposure to COVID-19, changes to procedures and policies, the use of remote tools that can effectively manage a facility that is sitting vacant, and monitor workforce health. You must have the correct information so that you can make a well-informed decision about which COVID-19 mitigation tool you’ll rely on. In some cases, depending on the size of your organization, it may be a good idea to use several mitigation methods.

Thermal Imaging Cameras Detect Body Temperatures

As much as we would like to find a vaccine or a cure for the current pandemic, it just hasn’t been found yet. This is why there are so many people busy trying to come up with ways to help us navigate through our new normal. Again, there are a lot of assumptions out there about what can help protect you against COVID-19. Thermal imaging does not cure COVID-19 nor does it detect a person with the virus. It simply serves to identify someone who may have a fever and thus may have the virus but no other symptoms are presenting themselves. There is a misconception that this equipment will find someone who has the virus and this is not true. It can detect someone who may potentially spread the disease without knowing that they have the virus. In some cases, some did not realize that they had an elevated temperature until they were scanned. After finding out, they have later found out that the elevated body temperature as an indicator of a much larger problem, COVID-19.

How Hospitals Use Thermal Imaging

Hospitals are not exempt. They require more screening than now more than ever. Some hospitals use more than one thermal imaging camera system at an entry point to further protect the patients who visit the facility. Some rely on a monitored system, that provides a  color-coded. If the temperature reads higher than 100 degrees or higher, they are required to step to the side for another type of screening. Despite someone having a higher than normal temperature, this doesn’t have to stop them from receiving visitors, as the systems allow them the efficiency that they need to continue operating. The hospitals have found the thermal camera very effective. Rather than using staff to check visitors’ temperature manually, they simply walk through the thermal imaging access point without stopping unless a higher than normal temperature is detected.

There has been some guidance from the Centers for Disease Control about containing COVID-19 in assisted living facilities, for health care providers, and other at-risk facilities, which advises them to install temperature check equipment. The Food and Drug Administration has relaxed some of its regulations regarding the type of thermal cameras that can be used so that more access to technology could be obtained. In March of 2020, the Equal Employment Opportunity Commission released new guidance for temperature checks in the workplace. It is becoming clear that there is something to be said about the effectiveness of this equipment. While no one would claim that it is 100% full proof, they would agree that it offers some significant degree of accuracy, which is why many businesses see the benefit of having it installed.

While the equipment can detect elevated temperatures, it cannot detect other symptoms that someone may have that may be related to COVID-19. Unfortunately, some have been led to believe that if they are asymptomatic that the thermal imaging camera would detect it. This couldn’t be further from the truth.

Sense of Security

Despite its inability to detect everyone who may potentially have COVID-19, having this type of screening is sure to give employees and visitors a sense of security. They may feel that since such precautions are being taken on their behalf that they are safe from the potential harm of contracting the virus. Some would argue that it gives people a false sense of security, however, this is up to the individual as to how they will respond to the use of thermal imaging.

Thanks to the innovative minds behind the thermal imaging camera, we can now begin to adjust to our new normal, no matter how short or how long it might be. Surprisingly, this type of invention that has been in place for decades is now being deployed to various businesses to ensure the safety of others. Even though it has been here the whole time, it wasn’t until the states began to open up that thermal imaging was recommended by the FDA and CDC as a way to mitigate the spread of COVID-19. Not everyone is aware of this type of equipment and they are still exhausting their resources by standing and physically taking the temperature of everyone who walks through their doors. This is not only time-consuming but it is inefficient, which is why it is in their best interest to at least learn about thermal cameras and how they can benefit them.

A Practical Solution

No one could have predicted that we would be in this spot today but we are and we have to make the most of it. Tons of new inventions are coming out every day but the ones that are practical and proven effective are the ones that are in use today, such as the thermal imaging camera that is so widely used throughout the world to help jump-start the economy. Research proves that we are better off with it than without it. With the variety of thermal imaging equipment available, there is something sure to suit the needs of everyone who needs to perform this type of mitigation. Again this is not a perfect solution but it is a practical solution for protecting others from COVID-19. Thermal imaging isn’t something that is going to change the current situation but it is an invention that is sure to make it easier for us to function.

from Long Island Locksmith | Nassau and Suffolk County Locksmith https://www.toplockny.com/the-new-normal-body-temperature-being-detected-by-innovative-thermal-imaging/