Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors
Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors
<h3>Importance</h3> Objective response rate (ORR) is an increasingly important end point for accelerated development of highly active anticancer therapies, yet its relationship to regulatory approval is not well characterized. <h3>Objective</h3> To identify circumstances in which a high ORR is associated with regulatory approval, and therefore might be an appropriate end …