Diversity Mandate for Clinical Trials Aids Review Boards’ Role

New clinical trial diversity requirements should help panels charged with ethics reviews of human studies, even if they don’t have to review the plans directly, research specialists said.

Drug and device companies and other clinical trial sponsors must submit a diversity action plan in the studies the Food and Drug Administration uses to decide whether to approve a medical product. The new requirement came about in the DEPICT Act (Public Law 117-164), which Congress enacted late in 2022.

DEPICT aims to address a longstanding challenge of underrepresentation in clinical trials. Racial and ethnic minorities make up almost 39% of ...