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June 28, 2024
Health Law Weekly

FDA Details Diversity Action Plan Requirements for Clinical Trials in Draft Guidance

  • June 28, 2024

The Food and Drug Administration (FDA) issued June 26 draft guidance discussing the requirements for Diversity Action Plans to help boost enrollment of underrepresented populations in clinical trials who may use the medical product being studied.

The draft guidance describes the format and content of Diversity Action Plans, when they are required, and the timing and process for submitting them to the FDA. The draft guidance also outlines the criteria and process for medical sponsors to request a waiver of the Diversity Action Plan requirement in certain studies.

The FDA said the Diversity Action Plans “must specify the sponsor’s rationale and goals for clinical study enrollment (separated by the age group, ethnicity, sex and race of clinically relevant study populations) and describe how the sponsor intends to meet those goals.”

New provisions added to the Federal Food, Drug, and Cosmetic Act require medical product sponsors to submit Diversity Action Plans for phase 3 clinical studies or “as appropriate” in other instances.

“Participants in clinical trials should be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.” 

The requirement to submit a Diversity Action Plan applies to clinical studies for which enrollment begins 180 days after publication of the final guidance, the FDA said. Comments on the draft guidance are due September 26.