The FDA recognizes that the COVID-19 pandemic can affect the conduct of clinical trials on medical products, including drugs, devices and biological products. Challenges may arise, for example, from quarantine, site closures, travel restrictions, supply chain disruptions for the experimental product or other considerations if site staff or trial subjects are infected with SARS-CoV-2, the virus which causes COVID- 19. These challenges can lead to difficulties in conducting clinical trials.
On Wednesday, the FDA released a guidance for running clinical trials during the pandemic, issuing the final document instead of issuing a draft guidance to solicit public comment, as it usually does. The agency said it recognized that Covid-19 may require sponsors to modify trial protocols, while illness and control measures related to the disease may make protocol deviations unavoidable
“With this guidance issued today, the FDA is helping industry and investigators navigate the COVID-19 pandemic and help assess how to move forward with critical clinical trials,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”
Just a few days ago, the Phase I clinical trial of the Moderna vaccine against Covid-19 virus dosed its first participant and Gilead Sciences’ remdesivir is being rushed to patients with infections from the novel coronavirus in hopes that it can reduce the intensity and duration of Covid-19 and ease the burden of the pandemic on health systems.