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Cancer Trials: FDA Wants Lower Performance Status Eligibility But Primary Analysis Exclusion OK

 
• By Sarah Karlin-Smith

New draft guidance pushes industry to broaden clinical trial eligibility criteria while offering some protection from fears it could hurt efficacy results.

group of diverse senior citizens sitting around a table
Increasing recruitment of older cancer patients for clinical trials seems to be one goal of the FDA's new performance status eligibility draft guidance. • Source: Shutterstock

The US Food and Drug Administration wants patients with a lower performance status included in cancer clinical trials to enhance generalizability and diversity and better understand the product's benefit-risk profile. But to assuage worries about the impact on outcomes, the agency also is willing to let sponsors exclude those lower-functioning patients from the study's primary efficacy analysis.

Including patients with low performance statuses (PS), a measure of how well a person performs ordinary tasks in daily living, in oncology trials may allow for faster trial accrual...

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