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FDA to Require Diversity Action Plan for Clinical Trials

Noel Hendrickson Photography / Stone via Getty Images Clinical trial
Public Law 117-328 underscores existing FDA recommendations on improving clinical trial diversity.

In April 2022, FDA released a draft guidance on improving enrollment for participants from underrepresented racial and ethnic populations in clinical trials. The guidance came in response to the frequent underrepresentation of Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and other Pacific Islander, and other people of color, in clinical research despite having what the Administration called a “disproportionate disease burden for certain diseases relative to their proportional representation in the general population.”

Now, Public Law 117-328, which was enacted in December of last year, is taking the guidance a step further by requiring diversity action plans for clinical trials used by FDA to decide drug and device safety and effectiveness. The law, which incorporates the DEPICT Act, addresses decades of testing drugs and devices primarily on White men, which has resulted in knowledge gaps on how treatments work on a large portion of the population. For example, in a 2020 study, study enrollment of Black Americans in clinical trials was reported as 4.5%. This is compared to the fact that Black Americans account for about 13% of the US population and 22% of yearly cancer cases.

The laws enactment requires investigators to develop a strategy for reaching a broad study population on the front end, instead of not doing so at all, or acting later, which increases an already costly and long clinical trial process.

“What’s happening with this plan is we’re all putting more focus and intentionality to how we do better with the sites to help them achieve the goals we need,” Rachael Fones, strategic adviser for diversity in clinical trials for the clinical research organization IQVIA, said in an article for Bloomberg Law.

Drug and device companies are now in the process of preparing for the new legal requirements and the official FDA guidance. Additionally, experts are urging institutions to not only increase diversity in trials, but also internally, with staff from clinical operations, ethics, and the compliance office.  

“The guidance is a great jump off point,” said Sarah Thompson Schick, an FDA regulatory attorney. “The legislation is a great jump off point. But where do we go next? Thinking about those governmental partnerships, and then also those inter-institutional partnerships to enhance diversity and developing those types of programs to get us there.”

TAGS: Testing
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