FDA guidance provides new details on diversity action plans required for certain clinical trials

(On June 26) the US Food and Drug Administration published a Draft guidelines, “Action plans to promote diversity 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 trials. Diversity action plans are designed to increase the enrollment of participants from historically underrepresented populations in clinical trials to improve the data the agency receives about the patients who may use the medical product.

Greater diversity within clinical trials not only facilitates the applicability of results to a broad range of patient populations, but also improves the understanding of the disease or medical device being studied, thus providing valuable insights for the safe and effective use of the medical device in patients.

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

This draft rule describes the format and content of diversity action plans, the medical products and clinical trials that require a diversity action plan, and the timing and process for submitting diversity action plans to FDA. The draft rule also outlines the criteria and process by which the agency will evaluate a sponsor’s request not to submit a required diversity action plan (also known as a waiver).

Diversity action plans must outline the sponsor’s rationale and goals for enrollment in clinical trials (broken down by age, ethnicity, gender, and race of clinically relevant study populations) and describe how the sponsor plans to achieve those goals. The guidelines also call on sponsors and investigators to consider the many dimensions of diversity in clinical trials, including those that go beyond age, ethnicity, gender, 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 arises 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 trials or, as appropriate, other pivotal clinical trials of a drug or biological product, and to certain clinical trials of devices, including those intended to serve as the primary basis for FDA’s evaluation of the safety and effectiveness and benefit-risk assessment of the device. The requirement to submit a diversity action plan applies to clinical trials for which enrollment begins 180 days after the final guidance is published.

“Generating data for a broader and more representative patient population early in the clinical development program is one of FDA’s priorities for bringing innovative medical products to the public. With FDORA, sponsors are now required to submit diversity action plans. These plans can help ensure sponsors think critically and intentionally about the many characteristics of the patient population they seek to treat when designing their clinical trial,” said Richard Pazdur, M.D., director of FDA’s Oncology Center of Excellence and deputy director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research.”

The draft guideline was developed by the Oncology Center of Excellence Project capital 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 guidelines should be submitted within 90 days of publication in the Federal Register to Regulations.gov. All written comments should be marked with the file number and title of the guide.

This press release was issued by the Food and Drug Administration on June 26, 2024.