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US FDA Commissioner Robert Califf Says No Formulas For Trial Diversity

 
• By Sarah Karlin-Smith

The FDA does not appear likely to provide a calculation for sponsors to show clinical trial diversity, but agency officials seem split on how tough to enforce the new regulations intended to ensure all groups are adequately represented.

BIO CEO John Crowley interview FDA Commissioner Robert Califf
BIO CEO John Crowley interviews FDA Commissioner Robert Califf during a 5 June BIO 2024 session. • Source: BIO Youtube page

Don’t expect population-specific quotas in the US Food and Drug Administration’s long-awaited guidance on diversity action plans for Phase III and pivotal trials.

Key Takeaways

  • Califf said quotas or set numbers to show clinical trial diversity will not be in an upcoming guidance.

  • He also thinks transparency about diversity plan contents will help improve minority representation in trials

“We have a new tool mandated by Congress … the diversity plan, which is a requirement for later phase trials that we’re going to learn it’s not like a set formula you have to put in the plan,” FDA Commissioner Robert Califf said 5 June during the Biotechnology

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