Sponsors Want Answers On Consequences Of Missing US FDA Trial Diversity Goals
No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.
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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.
Oncology sponsors would handle ex-US trial enrollment, but Pazdur feels tapping into the NCI network would improve trial speed and diversity. Biggest challenge will likely be generating sponsor enthusiasm for move that would involve giving up some control of development.
Keeping Track: AZ’s Imjudo, J&J’s Tecvayli Enter Burgeoning Immuno-Oncology Market; Genmab Submits Epcoritamab
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker