The US FDA will soon require those seeking approval for late-stage clinical trials to submit a plan for ensuring diversity among trial participants
To comply with the diversity requirement, researchers and pharmaceutical firms will need to list their demographic goals for the participant pool, their rationale for the goals and an explanation of how they intend to meet them. This process looks promising, says Jennifer Miller, a bioethicist at Yale School of Medicine in New Haven, Connecticut, and a co-author of the cancer-therapeutics analysis.
Aside from the time until implementation, researchers are concerned about a provision in the December spending bill that allows the FDA to waive the need for a diversity-action plan in certain circumstances; for example, during public-health emergencies, or if a disease or condition is not considered prevalent in the general population. This broad waiver authority takes the teeth out of the legislation, Hwang says.
Charles Kohler, a spokesperson for the FDA, says that the agency is committed to ensuring that trial participants reflect the populations that are likely to use the product, and that it is currently reviewing the powers that it was granted by the December legislation. Once the FDA implements its diversity requirement, it will be up to companies and researchers to recruit people to take part in their trials. To achieve their goals, they will have to focus on the structural problems that underlie the lack of diversity in clinical-trial populations, Miller says.
By itself, the legislation won’t be sufficient to address long-standing disparities in clinical-trial enrolment, Hwang says. But Knight says: “It’s fantastic the FDA is taking the approach.” It could even inspire countries such as the United Kingdom to introduce similar requirements, she adds. “Having these kinds of levers is the way to make researchers think about diversity.”
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