Menu Back toDo-the-End-point-s-Justify-the-Means-A-Peak-at-Endpoints-Accepted-by-FDA-With-an-Eye-Towards-Mobile-Technology-Collection

DIA 2018 Global Annual Meeting


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)
      Representative Invited

      Representative Invited

      • 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 P Turakhia, MD, MS

      Clinical Trials Using Mobile Technology

      Mintu P Turakhia, MD, MS

      • Senior Director, Center for Digital Health; Chief of EP, Palo Alto VA
      • Stanford University , United States
      Representative Invited

      FDA Perspective

      Representative Invited

      • FDA, United States
      Craig  Lipset, MBA

      Industry Perspective

      Craig Lipset, MBA

      • Head of Clinical Innovation, Global Product Development
      • Pfizer Inc, United States