Clinical Trial Diversity: PhRMA, Academia Lay Foundation For Network Of Community-Based Sites
PhRMA is funding an initiative to establish a network of sustainable, community-based trial sites. During 18-month proof of concept phase, 10 sites will receive training, technical support and mentorship.
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The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.
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.
No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.