FDA Issues New Draft Guidance to Promote Diversity in Clinical Trials

On April 14, 2022, the FDA released a new draft guidance to industry for increasing racial and ethnic diversity in clinical trials. The draft guidance, titled “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials,” recommends that sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan (referred to as the “Plan”) to the FDA before beginning clinical trials, based on a framework outlined in the guidance.

“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The draft guidance builds on the November 2020 final guidance, “Enhancing the Diversity of Clinical Trial Populations: Eligibility Criteria, Enrollment Practices, and Trial Designs,” and the October 2016 final guidance, “Collection of Race and Ethnicity Data in Clinical Trials.” In these previous documents, the FDA provided recommendations to sponsors on strategies to increase enrollment of underrepresented racial and ethnic populations, collect and present race and ethnicity data to the agency, and develop and submit a plan to address the inclusion of clinically relevant populations for discussion with the agency.

Barriers to participation among racial and ethnic groups may include mistrust of the clinical research system because of historic 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 healthcare system; and lack of awareness and knowledge about what a clinical trial is and what it means to participate may affect clinical trial participation among racial and ethnic minority populations.

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 address some of the obstacles that prevent diverse groups from participating in clinical trials. These barriers are addressed through a variety of strategies, tools, and resources, including 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 comment period for the draft guidance will close on June 13, 2022.

Related Articles

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: