This webinar will discuss the emergence and use of mobile health technologies in clinical trials and will provide information on U.S. regulatory considerations when including assessments from these devices to support endpoints in clinical trials as well as other use cases.  This webinar will also provide specific examples of the use of mobile health devices for evaluating treatment benefit.


There has been an increasing interest in using mobile health devices, including wearable devices, to collect patient health data remotely in clinical trials.

Learning Outcomes/Objectives

After the webinar, the learner will be able to:

  • Have an understanding of the types of mobile health devices being used in clinical trials today, and the benefits and challenges associated with the use of these devices
  • Look at how you can maximize the value of the data from the devices and sensors
  • Learn through specific examples how mobile health devices could be useful when evaluating treatment benefit in clinical trials
  • Have a better understanding of U.S. regulatory considerations related to use of mobile health devices in clinical trials


  • Marie McCarthy, Product Innovation, ICON plc
  • Wen-Hung Chen, Clinical Outcomes Assessment Staff, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Daragh Ryan, mHealth Program, Actelion Pharmaceuticals
  • Ken Skodacek, Clinical Trials Program & Payer Communications Task Force, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Paivi Miskala, MSPH PhD, Merck and Co., Inc.

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All ISOQOL webinars are planned and presented by ISOQOL member volunteers. Many are the collaborative efforts of one or more Special Interest Groups (SIGs).

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