Standardizing eligibility criteria: a new approach to ...
A collaborative effort by LUNGevity, FDA, NCI, and industry sponsors developed standardized eligibility criteria for NSCLC clinical trials, aiming to simplify criteria, enhance trial accessibility, and support inter-trial comparisons. The recommendations, forming the basis for FDA draft guidance, cover disease stage, biomarkers, performance status, and organ function, among others, to streamline trial design and improve patient access to novel therapies.
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A collaborative effort by LUNGevity, FDA, NCI, and industry sponsors developed standardized eligibility criteria for NSCLC clinical trials, aiming to simplify criteria, enhance trial accessibility, and support inter-trial comparisons. The recommendations, forming the basis for FDA draft guidance, cover disease stage, biomarkers, performance status, and organ function, among others, to streamline trial design and improve patient access to novel therapies.