Clinical Trial Diversity Measures Primed For Inclusion In US FDA User Fee Legislation
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.
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Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.
HHS is to evaluate the need for FDA authority to mandate postapproval studies or postmarket surveillance if sponsors do not meet diversity enrollment goals. By contrast, the DEPICT Act would have given the agency the authority to do so.
Rep. Dunn’s idea would be a return to prior agency practice; the documents are currently considered exempt from disclosure.