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
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
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
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
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
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
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
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