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Tuesday, June 20 • 10:30am - 11:45am
#227: At the Cornerstone of Wearable Technology and Patient-Focused Clinical Trial Endpoints

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

This session will cover aspects of design, implementation, and data analysis related to wearable devices. Case studies are strongly encouraged.

Learning Objectives

Discuss the regulatory framework, development and validation of instruments/devices, and analysis issues; Describe examples of use in clinical trials.


Leonard Sacks, MD


FDA Perspective
Nikunj B. Patel, PharmD

Industry Perspective
Robert A. DiCicco, PharmD

Academia Perspective
E. Ray Dorsey, MD, MBA

avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has ove... Read More →
avatar for E. Ray Dorsey

E. Ray Dorsey

David M. Levy Professor of Neurology and Director of the CHET, University of Rochester Medical Center
Dr. Dorsey is helping investigate new treatments for movement disorders and improve the way care is delivered for individuals with Parkinson disease and other neurological disorders. Using simple web-based video conferencing, he and his colleagues are seeking to provide care to i... Read More →
avatar for Nikunj Patel

Nikunj Patel

Clinical Outcome Assessments Reviewer, OND, CDER, FDA
Nikunj Patel is a clinical outcome assessment (COA) reviewer in the Office of New Drugs. Dr. Patel advises OND review divisions on COA-based endpoint development and implementation under the IND/NDA/BLA pathway. Additionally, he reviews qualification submissions under the COA typ... Read More →

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA
Dr. Sacks is the associate director for clinical methodology in the Office of Medical Policy at FDA. He is an infectious disease doctor by training with previous clinical experience in local and foreign hospitals. Since joining FDA in 1998, he has occupied various positions, as a... Read More →

Tuesday June 20, 2017 10:30am - 11:45am
S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616