USA – 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…