Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency on June 26 issued a new outline of its proposed requirements for the racial and ethnic diversity action plans that will eventually be mandatory components of studies on drugs, devices and other medical products.
“Participants in clinical trials should be representative of the patients who will use the medical products,” Robert Califf, M.D., FDA commissioner, said in a press release. “The agency’s draft guidance is an important step—and one of many ongoing efforts—to address the participation of underrepresented populations in clinical trials to help improve the data we have about patients who will use the medical products if approved.”
Within the 23-page document are details on how diversity action plans should be formatted, what they should include and how to submit them to the FDA. In short, companies are expected to set recruitment goals for different racial groups—stratified by age and gender—and to explain their rationale and strategies for doing so. The goals should be epidemiologically aligned with the prevalence of the condition the company’s product treats.
Some FDA-recommended strategies companies could take to meet diversity goals include engagement with communities and patient advocacy groups; making it easier for patients to participate in a trial, such as by providing transportation; reviewing study exclusion criteria; choosing trial sites located in areas with diverse populations; and decentralizing trials when necessary. The agency also recommended that sponsors publicize their recruitment strategies in the interest of transparency.
Diversity action plans are required for phase 3 trials or other pivotal clinical drug studies and investigational device exemption (IDE) applications for devices. If an IDE isn’t required for a device, companies should include them in any clinical studies expected to be the primary basis for an FDA approval, according to the guidance.
While the draft focuses on late-stage studies, the FDA encouraged companies to come up with comprehensive diversity plans that take into account the entire clinical development process, including early-stage trials, when possible.
Reacting to the news, GSK Head of Global Demographics and Diversity Michel Reid said in an emailed comment that the company “welcomes” the new guidance, “as diversifying our study populations is critical for advancing our understanding of new medicines and vaccines to ensure they have the biggest impact on patients.” So far, GSK has been ahead of other companies in implementing and being transparent about its trial diversity initiatives, a recent report from Trinity Life Sciences noted. All of the pharma’s phase 3 trials in 2022 and 2023 had diversity plans.
The public has until Sept. 26 to comment on the FDA guidance. Once the final draft is published, all companies that begin enrollment 180 days later will be required to submit diversity action plans.
The guidance is a manifestation of FDA and Biden administration’s efforts to make clinical trials more diverse, aims that were codified in 2022’s Food and Drug Omnibus Reform Act. Poor representation of Black, Indigenous, Latino or Latinx, Asian and other nonwhite populations is a long-standing, wide-ranging issue that undercuts the validity of studies on the safety and efficacy of medical products.