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

Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is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

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The agency describes what sponsors should include in the plan in a draft guidance, “Diversity Plans to Improve Enrollment...