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April 14, 2022

FDA issues new draft guidance to boost clinical trial diversity

Under the new guidance, medical product sponsors should submit a Race and Ethnicity Diversity Plan to the FDA.

The US Food and Drug Administration (FDA) has issued new draft guidance to the industry on how to develop plans for enrolling more subjects from underrepresented racial and ethnic populations in the country into clinical trials.

The latest guidance expands on the FDA’s prior guidance for the industry to enhance trial diversity.

Despite bearing an uneven burden for some ailments, racial and ethnic minorities remain underrepresented in biomedical research.

Clinical trials offer a key base of evidence for assessing if a medical product is safe and effective. As a result, enrolment in trials should have a diverse population.

The guidance advises that medical product sponsors should prepare and submit a Race and Ethnicity Diversity Plan to the FDA.

This plan needs to be submitted in the early clinical development stage and based on a framework mentioned in the guidance. 

The Office of Minority Health and Health Equity developed the ‘Diversity in Clinical Trials Initiative’ to support the efforts of the agency to boost the participation of a diverse population.

Barriers to participation can be overcome through various culturally and linguistically made strategies, tools and resources including multilingual educational materials, a specialised webpage with public service notices and videos, social media outreach and ongoing stakeholder engagement and partnerships. 

The guidances of the agency in enhancing trial diversity are in line with the goals of Cancer Moonshot, an initiative which was revived by the Biden Administration in February this year to further extend prevention, detection, research and patient care efforts in cancer.

A goal of this initiative is to address disparities in access to screening, diagnostics and treatment of cancer across gender, race, geography and resources. 

FDA commissioner Robert Califf said: “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. 

“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.”

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