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
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
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
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
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
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
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
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