The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S.
Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of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 in the early stages of clinical development, based on a framework outlined in the guidance.
The FDA said in a news release that, despite having a disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in biomedical research and, with clinical trials offering a crucial base of determining whether a medical product is safe and effective, clinical trial enrollment should reflect the diversity in the population that will ultimately use the product.
According to the FDA, the latest guidance aligns with the recently revived Cancer Moonshot initiative aimed at expanding cancer prevention, detection and patient care efforts across the federal government. One aspect of Cancer Moonshot is to address inequities in access to cancer screening, diagnostics and treatment across race, gender, region and resources.
“The U.S. 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,” FDA Commissioner Dr. Robert M. Califf said in the release. “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 [Biden] 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.”
The FDA cited barriers to participation among racial and ethnic groups, including mistrust of the clinical research system as a result of historical abuses, aspects to the trial design like inadequate recruitment and retention efforts, frequency of study visits, time and resource constraints for participants, transportation and participation conflicting with caregiver or family responsibilities.
Additional barriers include language and cultural differences, health literacy, religion, limited access within the healthcare system and a lack of awareness and knowledge about what clinical trials are and what it means to participate, the FDA said.
Some medtech companies have also undertaken efforts to address these barriers. Abbott has been conducting its Beyond Intervention initiative, an effort to improve patient care and quality of life. As part of the initiative, Abbott is focusing its clinical trials on including underserved communities such as women and people of color who are disproportionately affected by cardiovascular disease.
In support of the FDA’s efforts, the Office of Minority Health and Health Equity created the “Diversity in Clinical Trials Initiative,” which features public education and outreach to address the factors keeping diverse groups from participating in trials.
FDA’s draft guidance was developed by the Oncology Center of Excellence’s Project Equity, an initiative aimed at ensuring that data submitted to the FDA for the approval of oncology medical products adequately reflects the demographic representation of participants for whom the products are intended.