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At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints
Session Chair(s)
Leonard Sacks, MD
Director, Clinical Methodologies,Office of Medical Policy, CDER, FDA, United States
This session will cover aspects of design, implementation, and data analysis related to wearable devices. Case studies are strongly encouraged.
Learning Objective : Discuss the regulatory framework, development and validation of instruments/devices, and analysis issues; Describe examples of use in clinical trials.
Speaker(s)
Nikunj B. Patel, PHARMD
Director, Patient Reported Outcomes (Oncology) - Global Medical Affairs, AstraZeneca, United States
FDA Perspective
Robert DiCicco, PHARMD
Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Industry Perspective
E. Ray Dorsey, MD, MBA
David M. Levy Professor of Neurology and Director of UR CHeT , University of Rochester Center for Health and Technology, United States
Academia Perspective
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