FDA guidance advises sponsors on diversity action plans

A draft guidance published by the FDA on June 26, 2024, is intended to help medical product sponsors submit diversity action plans to support select clinical trials. The document Action plans to promote diversity to improve enrollment of participants from underrepresented populations in clinical trials will be open for comments on the FDA website until September 2024 (1,2).

Sponsors are now required to submit diversity action plans after the Food and Drug Omnibus Reform Act (FDORA) added new provisions to the Federal Food, Drug and Cosmetic Act (1). Diversity action plans must “describe the sponsor’s reasons and goals for clinical trial participation” and how the sponsor plans to achieve those goals, taking into account the age group, ethnicity, race, and gender of all clinically relevant populations, according to an FDA press release.

“Generating data for a broader and more representative population early in the clinical development program is one of FDA’s priorities for bringing innovative medical products to the public,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence (OCE) and deputy director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research (CDER), in the press release (1). “With FDORA, there is now a requirement for sponsors to submit Diversity Action Plans. These plans can help ensure sponsors think critically and intentionally about the many characteristics of the patient population they hope to treat when designing their clinical trial.”

The issuing offices for the draft guidance included OCE and CDER, along with the FDA Centers for Biologics Evaluation and Research and for Devices and Radiological Health, and the offices of the Commissioners of the Office of Minority Health and Health Equity and the Office of Women’s Health (2).

In general, the press release states, diversity action plans are intended to contribute to a better understanding of a disease or medical device under study while enabling a broader application of clinical trial results to different patient populations.

“Participants in clinical trials should be representative of the patients who will use the medical devices,” FDA Commissioner Robert M. Califf, MD, said in the press release (1). “The agency’s draft guidance is an important step – and one of many ongoing efforts – to encourage participation of underrepresented populations in clinical trials and improve the data we have about the patients who will use the medical devices if they are approved.”

In response to the release of the draft guidelines, Dr. Jeff Allen, President and CEO of Friends of Cancer Research, commented after attending a meeting on the topic at the White House.

“While FDA has long been committed to improving diversity in clinical trials, this new policy, required by Congress through the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, which was incorporated into FDORA, will provide a framework for diversity action plans,” said Allen (3). “Implementing these plans can be an important step forward in more comprehensively targeting clinical trials to patient populations that are often underrepresented and ensuring that critical trials are representative of the people who will ultimately receive new therapies.”

References

1. FDA. FDA guidance provides new details on diversity action plans required for certain clinical trials. Press release. June 26, 2024.
2. FDA approval. Draft guidance for industry, action plans to promote diversity to improve enrollment of participants from underrepresented populations in clinical trials (OCE, June 2024).
3. Comment received by email on June 26, 2024.