Clinical Trial Diversity Measures Primed For Inclusion In US FDA User Fee Legislation

18 Mar 2022

House subcommittee hears testimony on merits of various proposals to increase diversity of clinical trial participants; whether lawmakers ultimately favor measures that impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.

Game tokens — FDA user fee legislation is likely to include measures aimed at promoting more diversity in study enrollment. • Source: Alamy

US lawmakers showed strong support for attaching to Food and Drug Administration user fee legislation provisions aimed at increasing the diversity of clinical trials, but whether those measures will impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.

Four of the 22 bills discussed at a House Energy and Commerce Committee/Health Subcommittee legislative hearing on 17 March relate...