The FDA guidance provides new details on the diversity action plans required for certain clinical studies

Today, the US Food and Drug Administration issued a draft guidance, “Diversity action plans to improve enrollment of participants from underrepresented populations in clinical trials,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans aim to increase enrollment in clinical studies of participants from historically underrepresented populations to help improve the data the agency receives about patients who could potentially use the medical product.

Increased diversity within clinical studies not only facilitates the broader applicability of results to a broad spectrum of patient populations, but also increases understanding of the disease or medical product under study, thereby providing valuable insights to inform the use of safe and effective medical product by patients. .

“Participants in clinical trials must be representative of the patients who will use the medical products,” said FDA Commissioner Robert M. Califf, MD. populations underrepresented in clinical trials to help improve the data we have about patients who will use medical products if approved.”

This draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, and the timing and process for submitting Diversity Action Plans to FDA. The draft guidance also outlines the criteria and process the agency will use to evaluate a sponsor’s request not to submit a required diversity action plan, also known as a waiver.

Diversity Action Plans must specify the sponsor’s rationale and goals for clinical study enrollment (disaggregated by age group, ethnicity, gender, and race of clinically relevant study populations) and describe how the sponsor intends to meet those goals. . The guidance also urges sponsors and investigators to consider the many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex, and race to enroll populations that represent the patients who will be treated if the product is approved.

The requirement for sponsors to submit Diversity Action Plans comes from new provisions of the Federal Food, Drug, and Cosmetic Act, added by the Food and Drug Omnibus Reform Act (FDORA). These plans apply to phase 3 clinical studies or, as appropriate, other pivotal clinical studies of a drug or biological product, as well as to certain clinical device studies, including those intended to serve as the primary basis for safety evaluation by FDA. and the effectiveness and benefit-risk determination of the device. The requirement to submit a Diversity Action Plan applies to clinical studies for which enrollment begins 180 days after publication of the final guideline.

“Generating data on 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 can help ensure that sponsors think critically and intentionally about the multiple characteristics of the patient population they intend to treat when designing their clinical trial,” said Richard Pazdur, MD, director of the Oncology Center of Excellence. of the FDA and acting director of the Office of Oncology at the FDA’s Center for Drug Evaluation and Research.”

The draft guideline was developed by the Oncology Center of Excellence Project Equity in collaboration with 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 must be submitted within 90 days of publication in the Federal Register at Regulations.gov. All written comments should be identified by the document number and the title of the guidance document.

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