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US FDA Drug Center ‘Snapshots’ Show Progress, But Are They Measuring The Right Thing?

 
• By Michael McCaughan

US FDA trial enrollment data show improving enrollment across broad demographic definitions, but stakeholders agree more attention is needed for complex subgroups. Could larger trials be part of the answer?

diversity hands
Califf wants larger trials to better measure treatment effects in subgroups of interest. • Source: Shutterstock

US Food and Drug Administration Commissioner Robert Califf believes larger clinical trials may be necessary to ensure research adequately reflects the diverse needs of patients.

Key Takeaways

  • Robert Califf called for much larger clinical trials to ensure treatment effects can be studied in subgroups of interest.

During a recent National Academies of Science, Engineering and Medicine workshop on clinical trial diversity, Califf took a deliberately provocative...

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