FDA Issues Guidance On Clinical Trials During COVID-19

By Nach Davé

In March 2020, at the start of the COVID-19 pandemic, the FDA issued guidance on the conduct of clinical trials. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs, in a statement. “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.”

In line with the challenges created by the COVID-19 pandemic, the FDA provided some recommendations with regard to the conduct, monitoring, and data aspects of ongoing and future clinical trials. We’ve listed some of the key considerations for sponsors below. For more information, consult your project manager or contact Premier Research’s COVID-19 Task Force.