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Developing and Implementing Performance Outcome Assessments: Evidentiary, Methodological, and Operational Considerations

Richardson, Elizabeth and Burnell, Jessica and Adams, Heather and Bohannon, Richard and Bush, Elizabeth and Campbell, Michelle and Chen, Wen Hung and Coons, Stephen Joel and Papadopoulos, Elektra and Rooks, Daniel and 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
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

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