New York: The U.S. Food and Drug Administration (FDA) on Wednesday issued draft guidance recommending steps for drugmakers and medical device manufacturers to improve racial, ethnic, and other forms of diversity in their clinical trials.
The guidance provides suggestions for companies and researchers on how to establish and achieve goals for study enrollment. These goals should be segmented by age group, ethnicity, sex, and race. The FDA emphasized that these objectives should be clearly outlined in a “diversity action plan,” which details the strategies to meet these goals.
The primary aim of this guidance is to enhance the representation of diverse patient populations in clinical trials. Historically, certain groups, including Black Americans, have had lower participation rates in clinical trials, despite experiencing higher rates of certain diseases compared to the general population.
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Richard Pazdur, director of the FDA’s Oncology Center of Excellence, stated, “These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study.”
Although the guidance is not legally binding, it is typically adhered to by companies seeking FDA approval for their products. Under the 2022 Food and Drug Omnibus Reform Act, the FDA will require companies to submit plans on how they intend to increase diversity in studies for most new drugs and medical devices.
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The FDA also outlined the criteria and process for evaluating a manufacturer’s request to not declare their diversity goals. Improving access to clinical trials, such as by initiating studies in geographical areas with diverse populations, could help drugmakers achieve their enrollment targets.
The agency will seek public comments on the draft guidance for 90 days before finalizing it. All studies that begin enrollment within six months after the final guidelines are published will be required to comply with them.
