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Activity Number: 198 - Innovations in Patient-Focused Clinical Trials
Type: Contributed
Date/Time: Monday, August 8, 2022 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #322620
Title: Use and Potential Challenges of Consumer Wearable Devices in Clinical Trials
Author(s): T. Paulette Ceesay* and Vladimir Svetnik
Companies: Merck & Co and Merck Research Labs
Keywords: digital health technologies; potential challenges; experience

New methodologies and devices continue to be explored to evaluate the potential benefits of their use in various therapeutic areas. A pilot of an activity/sleep watch in the neuroscience therapeutic area in subjects with mild-moderate Alzheimer’s disease provided valuable experience with the use and potential challenges associated with digital health technologies for the assessment of sleep. This information should prove useful in the design of future outpatient trials where there is interest to use consumer wearable devices for the assessment of sleep/wake-related digital health outcomes. The information regarding the use of consumer wearable devices gleaned from this study may prove valuable to other therapeutic areas. This talk will discuss the challenges associated with digital health technologies and the potentially useful information that can be applied to future studies. Through statistical innovation, new methodologies can be constructed to address some of the complexities associated with analyzing this data. In the age of COVID, consumer wearable devices may be especially worthy of exploration since data collection can be done on an outpatient basis. 

Authors who are presenting talks have a * after their name.

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