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

June 02, 2022 by Alec Stone MA, MPA, Former ONS Director of Government Affairs and Advocacy

New draft guidance (https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials) from the U.S. Food and Drug Administration (FDA) facilitates enrolling more participants from underrepresented racial and ethnic U.S. populations into industry clinical trials. According to FDA, despite their disproportionate burden for certain diseases, racial and ethnic minorities are frequently underrepresented in research and expanding diversity in clinical trials is an important step to reduce those disparities.

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:

“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.”

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