Experts call for federal incentives to promote clinical trial diversity
A combination of federal incentives and regulations, similar to the approach used to increase pediatric drug development, is needed to increase the diversity of populations enrolled in US clinical trials of new drugs, according to a proposal from two policy experts.The proposal, outlined in a perspective piece in the New England Journal of Medicine, argues that current policies – mostly part of voluntary guidance from the Food and Drug Administration (FDA) – have not been sufficient to produce diversity in clinical trials.
“The FDA’s efforts to date have been aspirational and voluntary in nature without a mechanism for enforcement. Our proposal would be for a combination of incentives and regulations to encourage more representative and inclusive clinical trials for new medicines and devices,” Thomas J. Hwang, MD, of Brigham and Women’s Hospital and Dana-Farber Cancer Institute, both in Boston, told Regulatory Focus. Hwang co-authored the perspective piece with Otis W. Brawley, MD, of Johns Hopkins University in Baltimore.
Most recently, the FDA issued guidance to industry calling on drug sponsors to submit diversity action plans that include goals for study enrollment by demographic group and steps for achieving the enrollment goals (RELATED: Convergence: FDA officials urges big-picture focus in diversity planning for clinical trials, Regulatory Focus 13 September 2022). These diversity provisions were also included in an early version of a bill reauthorizing user fees for the FDA, though they did not make it into the continuing resolution passed in late September (RELATED: Sigh of relief as Congress reauthorizes user fee agreements, Regulatory Focus 30 September 2022).
While the diversity plan guidance and the legislative language to codify them represent a good “first step,” such diversity plans would not fully address underlying causes of lack of diversity in trials, such as restrictive eligibility criteria and costs of participation, the authors wrote.
Instead, the authors called on FDA to provide direct grants aimed at increasing enrollment capacity and infrastructure at clinical trial sites that are most likely to enroll participants from underrepresented populations. “Such support would help to ensure that efforts to include these facilities in clinical research do not result in undue burdens on clinical and ancillary staff or in delays in access to care, imaging, and services,” Hwang and Brawley wrote.
Additionally, they proposed that FDA clarify that some costs incurred by trial participants can be reimbursed, potentially lowering financial barriers to participation. FDA could also work with sponsors to ensure representative enrollment in postapproval studies is underway at the time of drug approval.
The authors called on Congress to offer financial incentives to drug manufacturers through new tax credits or the repurposing of part of the existing research-and-development tax credit. These incentives would be contingent on achieving sufficient diversity in trial enrollment for pivotal studies. Hwang and Brawley noted that tax credits are a better incentive than market exclusivity since extending market exclusivity can delay price decreases associated with generic market entry.
“With new federal incentives and regulations, policymakers and regulators can build a more sustainable infrastructure for inclusive drug development,” Hwang and Brawley wrote.
Brawley reported work as a consultant or board member for a variety of pharmaceutical companies. Hwang reported having no financial disclosures.
New England Journal of Medicine perspective
