Industry Seeks Flexibility, Clarity On US FDA Clinical Trial Diversity Action Plan Requirements

Draft guidance recommendations on setting enrollment goals lead PhRMA and BIO to seek assurances of FDA flexibility absent reliable disease prevalence data.

Flexibility ribbon
Industry wants FDA flexibility on setting enrollment goals for diversity action plans. • Source: Shutterstock

The US Food and Drug Administration should give sponsors flexibility in setting enrollment goals for clinical trial diversity action plans and further clarify how to balance enrollment between US and foreign sites in multinational studies, industry groups said.

Key Takeaways
  • Industry groups asked the FDA to provide an example of the type of diversity action plan required under FDORA.

  • PhRMA and BIO seek assurances that the agency will be flexible with enrollment goals in the absence of reliable disease prevalence data

Sponsors also want the option to submit a single diversity action plan for an entire clinical program rather

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