Back to Agenda
Session 6: Meaningful Score Changes to Establish Endpoint Definitions
Session Chair(s)
David H. Schubert
DH Schubert Regulatory Solutions LLC, 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)
Performance Based Measures
Dragos Roman, MD
FDA, United States
Associate Dir., Division of Gastroenterology & Inborn Errors Products, OND, CDER
Patient Reported Outcomes Status Update: Challenges, Observations, and (Some) Solutions from the Field
Alan Shields, PhD
Adelphi Values, United States
Vice President Patient Centered Outcomes
A Novel Method for Estimating Responder Thresholds
Karon Cook, PhD
Northwestern University, United States
Research Professor
Have an account?