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Do the End(point)s Justify the Means? A Peak at Endpoints Accepted by FDA With an Eye Towards Mobile Technology Collection
Session Chair(s)
Wayne Amchin
Senior Consumer Safety Officer, ORO, DRCHEN, OND, CDER
FDA, United States
This session will explore select endpoints FDA has already accepted in traditional clinical trials but which are now collectable using mobile technology in lieu of traditional means to obtain marketing approval, and the timing/options to engage FDA.
Learning Objective : Describe select endpoints FDA has already accepted in traditional clinical trials which may lend themselves to data collection using digital/mobile technology in clinical trials for marketing approval; Evaluate the challenges faced in adapting these endpoints to use of mobile technology; Apply this information to engage with the FDA early in your product development; Discuss the challenges.
Speaker(s)
Clinical Trials Using Mobile Technology
Mintu Turakhia, MD, MS
Stanford University , United States
Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA
FDA Perspective
Bakul Patel, MBA, MS
Google Health, United States
Senior Director, Global Digital Health Strategy and Regulatory
Industry Perspective
Stephen Amato, PhD
Pfizer Inc, United States
Project Manager for Digital Innovation
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