FDA publishes draft guidance on action plans for diversity in trials

June 27, 2024

The U.S. Food and Drug Administration (FDA) has published draft guidance detailing diversity action plan requirements for certain clinical trials.

The guidelines, entitled “Action Plans to Promote Diversity to Improve Enrollment of Participants from Underrepresented Populations in Clinical Trials,” aim to increase the representation of historically underrepresented populations in clinical research.

This approach aims to improve the quality and applicability of data for different patient groups.

The guidelines also describe the steps necessary for medical product sponsors to submit diversity action plans, which are now required for certain studies.

In addition, the FDA’s draft guidance states that diversity action plans should detail sponsors’ strategies for enrolling a diverse range of participants in terms of age, ethnicity, gender, and race.

These plans are critical to ensure that clinical trial results are applicable to a broader patient population and provide valuable insights into the safety and efficacy of medical products.

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The guidance also explains the types of medical devices and studies that require a diversity action plan, as well as the timing and process for submitting one to the FDA.

It also provides detailed criteria for evaluating exemption requests from sponsors seeking an exemption from the requirement to submit a plan.

The mandate for diversity action plans comes from the provisions of the Federal Food, Drug and Cosmetic Act, as amended by the Food and Drug Omnibus Reform Act (FDORA).

These plans are particularly relevant for Phase III or other clinical trials of assets, biological products, and certain device studies that form the basis for FDA’s safety, effectiveness, and benefit-risk assessments.

For studies that begin enrolling subjects 180 days after the publication of the final guidelines, there is an obligation to submit a diversity action plan.

FDA Commissioner Robert Califf said, “Participants in clinical trials should be representative of the patients who will use the medical products.”

“The agency’s draft guidance is an important step – and one of many ongoing efforts – to encourage the participation of underrepresented populations in clinical trials and thus improve the data we have on patients who will use the medical devices if approved.”