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Home » Topics » COVID-19

COVID-19
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COVID-19 Update

November 16, 2020
COVID-19 Drug Research Roundup Read More
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FDA Guidance Signals Clear Support for Efforts to Increase Trial Diversity

November 16, 2020
Leslie Ramsey
As part of its ongoing efforts to make clinical trials more representative of the population, the FDA last week issued a final guidance on what sponsors should do to make trials more accessible and appealing to under-represented racial, ethnic, gender and age groups. Read More

COVID-19 Update

November 9, 2020
COVID-19 Drug Research Roundup Read More

New Patient Enrollment Has Returned to Pre-Pandemic Levels, Survey Finds

November 2, 2020
Patient enrollment for global clinical trials is up 85 percent from the trough in April, the lowest point for clinical trial enrollment during the COVID-19 pandemic, according to a new survey. Read More

EMA to Release Previously Withheld Information on COVID-19 Trials

November 2, 2020
In a departure from its usual procedures, the European Medicines Agency (EMA) has announced it will release certain types of reports on COVID-19 trials not normally made public and will accelerate the publication timeline so that most information is available within one day of the agency’s receiving or taking action on trial submissions. Read More

COVID-19 Update

November 2, 2020
COVID-19 Drug Research Roundup Read More
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Site Crunch Challenges Made Worse by Pandemic, Eased with Sponsor Engagement

November 2, 2020
Charlie Passut and Leslie Ramsey
Sites are being asked to do more with less as revenues and resources decrease at the same time sponsor demands for COVID-related trials increase. But altering the dynamics between sites and sponsors may be part of the solution. Read More
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Pandemic Exacerbates Problem of Minority Underrepresentation in Trials

November 2, 2020
Charlie Passut
No matter how the data are crunched, the challenge remains that trials need to come up with new approaches for persuading reluctant minorities to participate in trials. And the problem has been exacerbated by the pandemic. Read More

Telehealth Acceptance Sees Major Uptick During Pandemic, BBK Worldwide Survey Finds

October 26, 2020
Approximately 64 percent of potential and former or current trial participants say they would like to have a combination of in-person visits and telehealth visits in future clinical trials, according to a new survey. Read More

FDA Advisory Committee to Develop Master Protocols for COVID-19 Vaccines

October 26, 2020
The FDA last week said it is developing master protocols for safety and effectiveness outcomes it intends to study for coronavirus vaccines. It will post the draft versions of those protocols for public comment and will eventually publish the final versions and final study reports online. The agency plans to identify and monitor 10 to 20 safety outcomes of interest, which will be done alongside the CDC and other government partners. Read More
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