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US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development

 
• By Bridget Silverman

Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.

Diversity
FDA provides guidance on improving diversity in clinical trial enrollment • Source: Alamy

Drug sponsors should submit a “Race and Ethnicity Diversity Plan” early in clinical development that can be revisited and revised throughout a drug’s regulatory life to enhance diversity in clinical trials, the US Food and Drug Administration advises.

The agency describes what sponsors should include in the plan in a draft guidance, “Diversity Plans to Improve Enrollment...

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