Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodological, and Operational Considerations
Richardson, Elizabeth, Burnell, Jessica, Adams, Heather, Bohannon, Richard, Bush, Elizabeth, Campbell, Michelle, Chen, Wen Hung, Coons, Stephen Joel, Papadopoulos, Elektra, Rooks, Daniel, Reeve, Bryce and Daniel, Gregory (2018) Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodological, and Operational Considerations. Therapeutic innovation & regulatory science. ISSN 2168-4804
Abstract
This is a white paper summarizing the key points made at a two-day meeting organized by the Duke University-Robert J. Margolis Center for Health Policy and the FDA on Performance Outcome Measures. The information from this meeting and this article will provide the basis for a FDA Guidance on the topic to be published in 2018.
Item Type: | Article |
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Keywords: | Performance outcome measure PerfO Clinical trial |
Date Deposited: | 11 Sep 2018 00:45 |
Last Modified: | 11 Sep 2018 00:45 |
URI: | https://oak.novartis.com/id/eprint/34510 |