In an effort to improve clinical trial diversity, the Food and Drug Administration (FDA) has issued a new draft guidance for developing plans to enroll more participants from underrepresented racial and ethnic populations into clinical trials in the US.

In the draft guidance titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials,” the Agency recommends sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan early in clinical development. The guidance aims to ensure that the data submitted to the FDA adequately represent the patients that will use the medical products.

Additionally, the Office of Minority Health and Health Equity has created the “Diversity in Clinical Trials Initiative” to help address the barriers of participation among racial and ethnic groups in clinical trials. Through a variety of tools and resources, the program will aim to address barriers to participation to ensure that individuals from diverse backgrounds join clinical trials in order to achieve health equity.

“The US 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,” said FDA Commissioner Robert M. Califf, MD “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.”

The Agency’s guidance on increasing diversity in clinical trials is aligned with the goals of the Cancer Moonshot initiative, which was revived in February 2022 by the Biden Administration to accelerate the rate of progress and research against cancer. One of the goals of the Cancer Moonshot initiative is to improve inequities and access to cancer screening, diagnostics and treatment across race, gender, region, and resources.

Reference

FDA takes important steps to increase racial and ethnic diversity in clinical trials. News release. US Food and Drug Administration. Accessed April 13, 2022. https://www.prnewswire.com/news-releases/fda-takes-important-steps-to-increase-racial-and-ethnic-diversity-in-clinical-trials-301524987.html