- U.S. Food and Drug Administration (FDA) (http://dev-voice.ons.org/topic/us-food-and-drug-administration-fda)
- Oncology Clinical Trials (http://dev-voice.ons.org/topic/oncology-clinical-trials)
- Diversity, Equity, Inclusion, and Connection (http://dev-voice.ons.org/topic/diversity-equity-inclusion-and-connection)
FDA Issues Draft Guidance on Diversity Action Plans for Certain Clinical Trials
Increasing clinical study enrollment of participants from historically underrepresented populations helps improve the quality of data used to approve a medical product, the U.S. Food and Drug Administration (FDA) said in a June 2024 press release (https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies). To achieve that goal, the agency released draft guidance for medical product sponsors to submit required diversity action plans for phase III and other types of clinical trials.
“Participants in clinical trials should be representative of the patients who will use the medical products,” FDA Commissioner Robert M. Califf, MD, said (https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies). “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data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The draft guidance was developed by the Oncology Center of Excellence’s Project Equity (https://www.fda.gov/about-fda/oncology-center-excellence/project-equity) in collaboration with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of Minority Health and Health Equity. According to the guidance, a diversity action plan must (https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies):
- Specify the sponsor’s rationale and goals for clinical study enrollment (separated by the age group, ethnicity, sex and race of clinically relevant study populations)
- Describe how the sponsor intends to meet those goals
- Consider the many dimensions of clinical trial diversity beyond age, ethnicity, sex, and race that represent the patients who will be treated if the product is approved.
The plans are required for phase III clinical studies or other pivotal clinical studies of a drug or biological product, as well as for certain clinical studies of devices, including those intended to serve as the primary basis for the FDA’s evaluation of the safety and effectiveness and benefit-risk determination of the device. Once the guidance is finalized, it will become effective for any qualifying clinical trials that begin enrollment 180 days after, FDA said (https://www.fda.gov/news-events/press-announcements/fda-guidance-provides-new-details-diversity-action-plans-required-certain-clinical-studies).
“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 the Food and Drug Omnibus Reform Act, 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,” Richard Pazdur, MD, 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, said.
The draft guidance is open for public comment (https://fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies) through September 26, 2024.
Learn more about increasing diversity in cancer clinical trials in the Oncology Nursing Podcast™ episode 260. Listen on your favorite podcast platform or using the player embedded below.