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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)
FDA Perspective
Nikunj B. Patel, PharmD
AstraZeneca, United States
Director, Patient Reported Outcomes (Oncology) - Global Medical Affairs
Industry Perspective
Robert DiCicco, PharmD
TransCelerate Biopharma Inc., United States
Vice President, Portfolio Management
Academia Perspective
E. Ray Dorsey, MD, MBA
University of Rochester Center for Health and Technology, United States
David M. Levy Professor of Neurology and Director of UR CHeT
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