FDA Issues Draft Guidance for Industry to Increase Racial and Ethnic Diversity in Clinical Trials

April 13, 2022—The FDA announced it has issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the United States into clinical trials.

The draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” recommends that sponsors of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 that is outlined in the guidance. The document was published in the Federal Register.

In the announcement, the FDA noted that the draft guidance expands on the agency’s previous guidance documents for industry to improve clinical trial diversity, including those of November 2020 and September 2017. All FDA guidance documents are available on the agency’s website here.

According to the FDA, racial and ethnic minorities are frequently underrepresented in biomedical research despite having a disproportionate burden for certain diseases.

The FDA stated that 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. The agency advised that 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.

According to the FDA announcement, barriers to participation among racial and ethnic groups may include mistrust of the clinical research system because of 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 said it 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, health care 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.

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.

Because 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.

The FDA noted that 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, which is composed 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, stated the announcement.

“The United States population has become increasingly diverse and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” commented FDA Commissioner Robert M. Califf, MD, in the agency’s announcement. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities. This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics, and clinical trials.”