FDA Issues Draft Guidance on Diversity Action Plans

07/08/2024|3 minute read

Key Takeaways:

• Sponsors of certain clinical studies will be required to submit a Diversity Action Plan, and all clinical trial sponsors are strongly encouraged to adopt strategies for increasing the enrollment of underrepresented demographic groups.
• A Diversity Action Plan must describe the sponsor's goals for enrollment, rationale for the goals and strategies to achieve the goals.
• Compliance with the guidelines for Diversity Action Plans will become mandatory for clinical trials beginning enrollment after 180 days from the date the FDA publishes its final guidance.

On June 26, 2024, the U.S. Food and Drug Administration (FDA) issued draft guidance setting forth detailed requirements for the submission of Diversity Action Plans (DAPs) by sponsors of certain clinical studies involving drugs, devices and biological products. This guidance was issued pursuant to the Food and Drug Omnibus Reform Act of 2022, and it replaces the FDA's prior guidance for diversity plans. Compliance will be mandatory for clinical trials where enrollment starts 180 days after the final guidance is published.

The purpose of requiring DAPs is to increase the enrollment of underrepresented populations in clinical studies, thereby improving the generalizability and robustness of clinical data. Specifically, DAPs will be focused on recruiting study participants from populations that are underrepresented based on race, ethnicity, sex or age.

In this guidance, the FDA provides extensive instructions reflecting its expectations for the content of DAPs. The primary requirements are that a DAP must describe the sponsor's (1) goals for enrollment, (2) rationale for the goals and (3) strategies to achieve the goals.

Enrollment goals are to be disaggregated by race, ethnicity, sex and age group. This disaggregation will ensure that study participants reflect the demographic profile of the patient population that will use the medical product.

A sponsor's rationale for its enrollment goals should include an overview of the natural history of the disease or condition for which the medical product is being investigated. The rationale should also address risk factors and the demographic prevalence of the relevant disease or condition.

With respect to strategy, the guidance emphasizes the importance of early engagement with the FDA to formulate a plan for achieving enrollment goals. Sponsors are encouraged to proactively identify potential barriers to enrollment, such as geographic location and socioeconomic status, and to implement strategies to mitigate these barriers.

The guidance outlines the procedures for submitting DAPs to the FDA and receiving feedback from the agency. Sponsors are required to submit DAPs as part of their clinical study applications and to update the FDA on their progress toward meeting enrollment goals in annual reports. Notably, the guidance allows for DAPs to be modified based on FDA feedback or new information, ensuring that the plans remain appropriately tailored throughout the clinical trial process.

The FDA may grant full or partial waivers of DAP requirements in certain circumstances, including where there are insufficient data available on the demographic prevalence of the relevant disease or condition, when conducting a study in accordance with a DAP would be impracticable, or if a waiver is necessary to protect the public during a public health emergency. However, considering the importance of diversity in clinical research, the FDA expects such waivers to be rare and well-justified.

Overall, the FDA guidance on Diversity Action Plans represents another significant step toward more inclusive clinical trials that will hopefully improve the understanding of diseases and medical products under study and inform the safe and effective use of those medical products for all patient populations.

For additional information, please contact your BakerHostetler contact or the attorneys listed with this alert. The public comment period for this draft guidance will end on Sept. 26, 2024.

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