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Clinical Trial Diversity Planning Requires Prevalence-Based Enrollment Goals, Metrics For Gauging Success

 
• By Sue Sutter

Academic and industry experts caution against relying on historical enrollment numbers when setting new targets for under-represented populations and tout real-time monitoring dashboards, as well as a role for data monitoring committees, in assessing whether targets are being met in ongoing studies.

Blind spot
Beware of blind spots when looking for prevalence information on under-represented populations in health care databases. • Source: Shutterstock

Development of clinical trial diversity plans for regulatory submission involves careful setting of enrollment targets based upon current prevalence data, not just historical enrollment numbers, and multiple approaches for assessing whether diversity goals are being achieved.

Industry and academic experts discussed establishment of clinical study enrollment goals and use of disease prevalence data, as well as potential measures for incentivizing enrollment of more diverse populations, at...

Key Takeaways

  • Registries are a good source of prevalence date for setting enrollment targets for diverse populations.

  • The participation-to-prevalence ratio is a widely touted, but less...

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