Gnanasakthy of Novartis published a recent review article exploring use of PROs as primary and nonprimary endpoints for tx benefit for NMEs and BLAs in US, between 2000-2012. Of 308 NMEs/BLAs, 70 (23%) were granted PRO claims, mostly for disease- or condition-specific signs and symptoms. Of those 70 claims, a PRO was a primary endpoint for the vast majority (57 [81%]). Interestingly, 19 of the 70 products were granted a PRO claim based on a nonprimary endpoint. More here. (Source: Health and Quality of Life Outcomes journal, 2013)
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