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New draft guidance pushes industry to broaden clinical trial eligibility criteria while offering some protection from fears it could hurt efficacy results.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of older cancer patients for clinical trials seems to be one goal of the FDA's new performance status eligibility draft guidance.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

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