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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)
Mintu Turakhia, MD, MS
Executive Director, Center for Digital Health; Chief of EP, Palo Alto VA, Stanford University , United States
Bakul Patel, MBA, MS
Sr. Director, Global Digital Health Strategy and Regulatory, Google, United States
Stephen Amato, PHD
Project Manager for Digital Innovation, Pfizer Inc, United States
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