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Advancing the Science of Study Endpoints


Session 8: The Emerging Role of Novel Devices in Collecting Real-Time Data

Session Chair(s)

Keith  Wenzel

Keith Wenzel

  • Senior Director, Scientific Data Organization
  • Parexel International, United States
Within clinical trials, there is optimism that connected medical devices can be used to collect novel endpoints, to give greater insight into a study subject’s health status, to provide benefits of investigational products, and to further the understanding of the safety and efficacy of investigational products. There is also some hesitancy around connected sensors, however, due to the lack of formal guidance from regulatory authorities. The challenge today is not deciding on whether to use a mobile health device, but rather the effective integration of the device into the study. This session will explore the current state of the science for connected medical devices to collect meaningful study endpoints in clinical trials.
Learning Objective : Upon completion of this session, participants should be able to:
  • Describe the current state of the science when using medical devices to collect study outcomes
  • Describe the lessons learned from real-world use of medical devices in clinical trials

Speaker(s)

Michael  King

Exploration of Six Sensing Devices as Study Endpoints

Michael King

  • Senior Director, Diabetes Project Leader
  • Sanofi, United States
Martin  Ho, MS

A Regulator’s Perspective on Novel Endpoints and Patient Preferences in Medical Devices

Martin Ho, MS

  • Associate Director, Office of Biostatistics and Epidemiology, CBER
  • FDA, United States

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