Surrogate End Points and Patient-Reported Outcomes for Novel Oncology Drugs Approved Between 2011 and 2017.

Zettler, Marjorie; Basch, Ethan; Nabhan, Chadi · JAMA Oncol · 2019

review · Level V

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Abstract

This review of novel oncology drugs approved by the US Food and Drug Administration examines the use of surrogate end points for overall survival, evaluates the use of patient-reported outcomes in trials supporting approvals, and seeks to determine whether drugs initially approved without evidence of overall survival or patient-reported outcome benefits demonstrate improvements in either measure postapproval.