FDA Issues New Guidance to Increase Racial and Ethnic Diversity in Clinical Trials

The agency’s focus on inclusion in trials for all medical products aligns with Biden Administration’s Cancer Moonshot goal of addressing inequities and beyond.

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The U.S. Food and Drug Administration has issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials—expanding on the agency’s previous guidances for industry to improve clinical trial diversity.

Despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research. Clinical trials provide a crucial base of evidence for evaluating whether a medical product is safe and effective; therefore, enrollment in clinical trials should reflect the diversity of the population that is ultimately going to use the treatment. It is known that biological differences exist in how people respond to certain therapies. For example, variations in genetic coding can make a treatment more or less toxic for one racial or ethnic group than another. These variations can also make drugs like antidepressants and blood-pressure medications less effective for certain groups.

The draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance.

Barriers to participation among racial and ethnic groups may include mistrust of the clinical research system due to historical abuses, aspects of the trial design such as inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities. In addition, language and cultural differences, health literacy, religion, limited access within the health care system and a lack of awareness and knowledge about what a clinical trial is and what it means to participate may impact clinical trial participation among racial and ethnic minority populations. 

The FDA remains committed to increasing enrollment of diverse populations in medical product and drug development and will continue to engage with federal partners, medical product manufacturers, healthcare professionals and health advocates to reach this important goal.

To support the FDA’s efforts to advance diverse participation, the Office of Minority Health and Health Equity created the “Diversity in Clinical Trials Initiative,” which includes an ongoing public education and outreach campaign to help address some of the barriers preventing diverse groups from participating in clinical trials. Barriers to participation are addressed through a variety of culturally and linguistically tailored strategies, tools and resources such as: educational materials in multiple languages, a dedicated webpage with public service announcements and videos, social media outreach and ongoing stakeholder engagement, collaborations, and partnerships.

In February, the Biden Administration revived the Cancer Moonshot initiative to further expand cancer prevention, detection, research, and patient care efforts across the federal government. The FDA Commissioner serves as a member of the White House Cancer Cabinet, comprised of departmental agencies and components organized to develop a unified strategy in the fight against the disease. One of the goals of the Cancer Moonshot is to address inequities in access to cancer screening, diagnostics and treatment across race, gender, region, and resources. The FDA’s guidances on increasing diversity in clinical trials are aligned with the Cancer Moonshot goals.

The draft guidance was developed by the Oncology Center of Excellence’s Project Equity, which aims to ensure that the data submitted to the FDA for approval of oncology medical products adequately reflects the demographic representation of participants for whom the medical products are intended. As this guidance applies to all medical products, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health also contributed to this collaborative effort.  

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