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Home » Topics » COVID-19

COVID-19
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Analyze Data Validity to Identify Impact of COVID-19 Disruptions, Expert Says

October 26, 2020
Charlie Passut
Sites and sponsors should conduct certain analyses with their trial data during COVID-19 to determine empirically whether their data capture methods remain valid because of the impact the pandemic is having on how patients are reporting outcomes. Read More

Japan Publishes COVID-19 Vaccine Trial Principles

October 19, 2020
In newly released guidelines, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) recommends using confirmed SARS-CoV-2 infection, arterial oxygen saturation, requirement of oxygen therapy and death as key study endpoints for clinical trials evaluating COVID-19 vaccines.  Read More

NIH Studying Approved and Investigational Therapies for Use Against COVID-19

October 19, 2020
The National Institute of Allergy and Infectious Diseases (NIAID) has begun a phase 2 study of the potential of approved therapies and late-stage investigational drugs for hospitalized COVID-19 patients. Read More

Diversity Challenges Slow Enrollment of Moderna’s Late-Stage COVID-19 Vaccine Trial

October 12, 2020
Moderna has slowed enrollment of its phase 3 COVID-19 vaccine trial because it is experiencing challenges recruiting enough Black, Latino and Native American participants. The Cambridge, Mass.-based biotech company suggests this lack of diversity is preventing researchers from understanding how its COVID-19 vaccine candidate works in minority populations. Read More

EMA Publishes Nine Q&As Discussing New DMC Guidelines

October 12, 2020
A new guideline from the European Medicines Agency (EMA) provides recommendations on how data monitoring committees (DMC) should proceed when considering stopping a trial. Read More

Medical Experts Urge FDA to be Tougher on COVID-19 Vaccine Trial Monitoring

October 12, 2020
Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials. Read More

COVID-19 Update

October 12, 2020
COVID-19 Drug Research Roundup Read More

COVID-19 Prevention Network Deploys Mobile COVID-19 Vaccine Trials

October 5, 2020
The National Institute of Allergy and Infectious Diseases (NIAID) has partnered with Matrix Medical Network to help more than 20 academic medical centers involved in NIAID’s COVID-19 Prevention Network establish mobile health clinics at universities, hospitals and other locations across the U.S. Read More

COVID-19 Update

October 5, 2020
COVID-19 Drug Research Roundup Read More
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T Cells Could Play Crucial Role in COVID-19 Vaccine and Treatment Trials, Experts Say

October 5, 2020
Leslie Ramsey
The first wave of COVID-19 vaccine development has not monitored the response of T cells to the virus, a missed opportunity that should be addressed in the next wave of COVID-19 research, two experts said last week. Read More
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