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Sponsors Want Answers On Consequences Of Missing US FDA Trial Diversity Goals

 
• By Derrick Gingery

No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.

diversity
Sponsors are hoping clinical trial diversity guidance updates will include more clarity on FDA actions when enrollment goals are missed. • Source: Shutterstock

Sponsors want more information about the potential consequences of failing to meet clinical trial diversity goals, but a US Food and Drug Administration official says worrying about penalties misses the point of the effort.

FDA officials have yet to take a negative action against a sponsor for missing diversity targets in an oncology clinical trial, although the issue has emerged as a consideration when applications are assessed

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