FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19

On March 18, 2020, the Food & Drug Administration (FDA) issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practices and minimizing risks to trial integrity. Considerations recommended include, among others, sponsors evaluating alternative methods for assessments, like phone contacts or virtual visits and offering additional safety monitoring for those trial participants who may no longer have access to the investigational product or the investigational site.

On March 16, 2020, the National Institutes of Health (NIH) issued Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 that provides information related to participant safety, sites, reporting, research delays and cost.