Open AccessResponse Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors
Author(s) -
Geoffrey R. Oxnard,
Katharine H. Wilcox,
Mithat Gönen,
Mikhael Polotsky,
Bradford R. Hirsch,
Lawrence H. Schwartz
Publication year - 2016
Publication title -
jama oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 8.846
H-Index - 99
eISSN - 2374-2445
pISSN - 2374-2437
DOI - 10.1001/jamaoncol.2015.6315
Subject(s) - medicine , clinical endpoint , clinical trial , regimen , surrogate endpoint , response evaluation criteria in solid tumors , cancer , oncology , phases of clinical research
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.
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