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Session 6: Meaningful Score Changes to Establish Endpoint Definitions
Session Chair(s)
David H. Schubert
, United States
Working from the starting point that the concepts we are measuring are meaningful, and that the instruments for measuring these have been developed according to industry standards and have demonstrated measurement properties. It is next necessary to determine what is a meaningful score change in order to establish endpoint specification prospectively. This interactive session will integrate audience status and opinion feedback via their Smartphones.
Speaker(s)
Dragos Roman, MD
Associate Dir., Division of Gastroenterology & Inborn Errors Products, OND, CDER, FDA, United States
Performance Based Measures
Alan Shields, PHD
Vice President Patient Centered Outcomes , Adelphi Values, United States
Patient Reported Outcomes Status Update: Challenges, Observations, and (Some) Solutions from the Field
Karon Cook, PHD
Research Professor, Northwestern University, United States
A Novel Method for Estimating Responder Thresholds
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