FDA issues draft guidance on diversity in clinical study enrollment

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The U.S. Food and Drug Administration (FDA) has issued a draft guidance document intended to assist medical product sponsors with improving enrollment of clinical study participants through Diversity Action Plans.

This draft guidance describes the format and content of Diversity Action Plans, the medical products and clinical studies for which a Diversity Action Plan is required, as well as the timing and process for submitting Diversity Action Plans to the FDA. The draft guidance also describes the criteria and process the agency will use to evaluate a sponsor’s request to be granted a waiver. 

The draft guidance was developed by the Oncology Center of Excellence Project Equity in collaboration with the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Office of Women’s Health, and the Office of Minority Health and Health Equity.

The requirement for product sponsors to submit Diversity Action Plans comes from new provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act (FDORA). It applies to phase III clinical studies of a drug or biological product, as well as for certain clinical studies of devices, including those intended to serve as the primary basis for the FDA’s evaluation of the safety and effectiveness and benefit–risk determination of the device. 

Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations. Not only does a more diverse study population ensure broader applicability of results across a broader spectrum of patient populations, but it also helps improve the data the agency receives about patients who may potentially use the medication or test, the FDA noted in a statement. 

Comments on the draft guidance may be submitted at the link; all comments should be submitted within 90 days after publication in the Federal Register to Regulations.gov.         

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