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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Clinical Trial Diversity Action Plans Required Under US Funding Bill
Omnibus legislation requires FDA to issue guidance documents and hold public workshops on clinical trial diversity, but it does not give the agency authority to mandate postmarketing studies if a preapproval trial falls short of demographic diversity goals.
Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say
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.
Clinical Trial Diversity: User Fee Bill Wants FDA’s Assessment Of Whether It Needs More Authority
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.