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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
Director, Patient Reported Outcomes (Oncology) - Global Medical Affairs, AstraZeneca, United States
Industry Perspective
Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Academia Perspective
David M. Levy Professor of Neurology and Director of UR CHeT , University of Rochester Center for Health and Technology, United States
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