FDA And NIH Release Guidance On Ongoing Clinical Trials Affected By COVID-19

The COVID-19 pandemic has had a major impact on the conduct of clinical trials worldwide. Restrictions on travel, dislocation of clinical trial subjects, and the need of many health care facilities to handle an influx of patients with COVID-19 have combined to disrupt the conduct of clinical trials. This has led to sponsors, investigators, and institutional review boards (IRBs) needing to make quick decisions regarding whether to make modifications to, or even to suspend, many clinical trials. Recognizing the impact of COVID-19 on clinical trials, on March 16 and March 18, 2020 the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA), respectively, released guidance regarding the conduct of clinical trials during the COVID-19 pandemic. This alert summarizes both sets of guidance and notes certain considerations for clinical trial sponsors and sites.