FDA’s Industry Guidance Will Increase Racial and Ethnic Diversity in Clinical Trials

In the April 2022 guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations),” FDA recommended that medical product trial sponsors submit a race and ethnicity diversity plan to FDA early in clinical development based on a framework. The recommendation builds on work from the U.S. Department of Health and Human Services Office of Minority Health and Health Equity (https://www.minorityhealth.hhs.gov/)’s Diversity in Clinical Trials Initiative (https://www.fda.gov/consumers/minority-health-and-health-equity/clinical-trial-diversity) that addresses the barriers preventing diverse groups from participating in clinical trials through a public education and outreach campaign.

According to FDA, clinical trials provide (https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials) a crucial evidence base for evaluating a medical product’s is safety and efficacy and clinical trials should reflect the diversity of the population that will use the treatment. However, barriers (https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials) to enrollment and participation prevent diversity in clinical trials, such as:

• 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 of family responsibilities
• Language and cultural differences
• Health literacy
• Religion
• Limited access across the healthcare system
• A lack of awareness and knowledge about what a clinical trial is and what it means to participate

“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 Robert M. Califf, MD, said (https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials). “Going forward, achieving greater diversity will be a key focus throughout 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 (https://voice.ons.org/advocacy/president-biden-reignites-cancer-moonshot-initiative) 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.”