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Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

 
• By Sue Sutter

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.

Carrot and stick
Regulatory incentives could serve as the 'carrot' to counterbalance the FDA's guidance 'stick.' • Source: Shutterstock

The US Food and Drug Administration and Congress should consider regulatory and financial incentives to reward drug sponsors who achieve certain thresholds of enrollment diversity in their clinical trials, two attorneys said.

Speaking at a recent Food and Drug Law Institute conference on clinical trial challenges, attorneys Sarah Thompson Schick and Winston Kirton said incentives such as use of expedited regulatory pathways, extended marketing exclusivity and tax credits could complement current agency guidance, as well as recent

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