FDA planning to work with sponsors to salvage trials damaged by COVID-19
Flexibility in interpreting trial data needed to reduce effect pandemic is having on biomedical progress
COVID-19 has disrupted clinical trials around the world, causing sponsors to wrap up studies sooner than anticipated, modify protocols to allow for remote collection of data, and in some cases contemplate methods to compensate for missing data. Regulatory flexibility in interpreting these trials will be needed to reduce the damage the pandemic is causing to biomedical progress.
Senior FDA officials Thursday said the agency is aware of the challenges and is developing plans to help sponsors salvage trials that were interrupted or degraded by the