Reported outcomes as primary endpoints in confirmatory clinical trials

Gnanasakthy A, Lewis S, Clark M, Evans E, Mordin M, DeMuro C. Reported outcomes as primary endpoints in confirmatory clinical trials. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A200.

The purpose of this research was to determine the impact of patient-reported outcome (PRO) endpoint type (primary vs. nonprimary) on PRO-based labeling claims. This review examines PROs as both primary and nonprimary endpoints used to demonstrate treatment benefit of new molecular entities (NMEs) and biologic license applications (BLAs) in the United States (US) in the years 2000-2010.

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Gnanasakthy A, Lewis S, Clark M, Evans E, Mordin M, DeMuro C. Reported outcomes as primary endpoints in confirmatory clinical trials. Poster presented at the 2012 ISPOR 17th Annual International Meeting; June 2012. Washington, DC. [abstract] Value Health. 2012 Jun; 15(4):A200.