FDA lays out strategies for promoting diversity in clinical trial enrollment

The US Food and Drug Administration (FDA) is encouraging drug and biologics sponsors to broaden enrollment criteria and to avoid unnecessarily excluding participants in a final guidance document aimed at increasing the diversity of clinical trial participants.

“To further promote and protect public health, it is important that people who are in clinical trials represent the populations most likely to use the potential medical product,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.