The U.S. Food and Drug Administration (FDA) has released a draft guidance document titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies.” This guidance is aimed at helping medical product sponsors create and submit Diversity Action Plans, which are crucial for enhancing the enrollment of participants from historically underrepresented populations in clinical studies.

The FDA emphasizes that increasing diversity in clinical studies not only broadens the applicability of study results across diverse patient populations but also enriches the understanding of diseases and the medical products under study. This, in turn, provides valuable insights to ensure the safe and effective use of these medical products among varied patient groups.

“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of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, M.D. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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The draft guidance outlines the required format and content for Diversity Action Plans, detailing the medical products and clinical studies necessitating such plans. It also specifies the timing and process for submitting these plans to the FDA. Furthermore, the guidance elaborates on the criteria and procedure for sponsors to request a waiver from submitting a required Diversity Action Plan.

According to the guidance, Diversity Action Plans must articulate the sponsor’s rationale and objectives for clinical study enrollment, categorized by age, ethnicity, sex, and race of the relevant study populations. Additionally, sponsors are encouraged to consider other dimensions of diversity to ensure that the study populations are representative of those who will ultimately use the product if approved.

The mandate for submitting Diversity Action Plans stems from new provisions in the Federal Food, Drug, and Cosmetic Act introduced by the Food and Drug Omnibus Reform Act (FDORA). These plans are necessary for phase 3 clinical studies or other pivotal clinical studies of drugs, biological products, and certain medical devices that serve as the primary basis for the FDA’s evaluation of safety, effectiveness, and benefit-risk determinations. This requirement applies to clinical studies whose enrollment begins 180 days after the final guidance publication.

“Generating data for a broader and more representative population early in the clinical development program is among the FDA’s priorities to bring innovative medical products to the public. With FDORA, there is now a requirement for sponsors to submit diversity action plans. These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

The draft guidance was developed by the Oncology Center of Excellence Project Equity in collaboration with several FDA centers, including the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of Minority Health and Health Equity.

Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to

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