The US Food and Drug Administration (FDA) urged drugmakers and medical device manufacturers on Wednesday, June 26, to improve racial and cultural diversity in clinical trials. 

According to the FDA, the draft guidelines include recommendations for businesses and academics running trials on defining and communicating study enrollment goals broken down by age range, ethnicity, gender, and race. 

Increasing Clinical Trial Representation of Underrepresented Groups

The purpose of these FDA recommendations is to increase the representation of underrepresented groups in clinical trials, as specific groups have historically had lower participation rates, such as Black Americans while having greater prevalence of certain illnesses overall, Reuters reported.

The FDA said that while establishing research objectives, the so-called "diversity action plan" should be based on the anticipated disease prevalence for which the medication or technology is being tested.

Richard Pazdur, head of the FDA's Oncology Center of Excellence, said incorporating these strategies into a clinical trial's design may encourage sponsors to carefully consider the diverse patient group they are studying.

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FDA to Require Businesses to Publish Plans for Diversified Studies

Under the Food and Drug Omnibus Reform Act of 2022, businesses must submit plans outlining strategies to enhance diversity in research on most new medications and medical devices.

Also, the guidelines for how the agency would assess a manufacturer's request to withhold its objectives are detailed. Pharmaceutical companies should improve access to clinical trials by starting research in geographical regions with different demographics to reach their enrollment targets.

The agency will have a 90-day feedback window on the proposed guidelines before finalization. Within six months after the final guidelines' publication, all studies enrolling participants must adhere to them.

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