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.
Cancer Trials: FDA Wants Lower Performance Status Eligibility But Primary Analysis Exclusion OK
New draft guidance pushes industry to broaden clinical trial eligibility criteria while offering some protection from fears it could hurt efficacy results.
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