Wearable Devices in Clinical Trials: Hype and Hypothesis

Elena S Izmailova, John A Wagner, Eric D Perakslis, Elena S Izmailova, John A Wagner, Eric D Perakslis

Abstract

The development of innovative wearable technologies has raised great interest in new means of data collection in healthcare and biopharmaceutical research and development. Multiple applications for wearables have been identified in a number of therapeutic areas; however, researchers face many challenges in the clinic, including scientific methodology as well as regulatory, legal, and operational hurdles. To facilitate further evaluation and adoption of these technologies, we highlight methodological and logistical considerations for implementation in clinical trials, including key elements of analytical and clinical validation in the specific context of use (COU). Additionally, we provide an assessment of the maturity of the field and successful examples of recent clinical experiments.

© 2018 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Figures

Figure 1
Figure 1
The timeline for market release of technologies enabling wearable device use in healthcare.
Figure 2
Figure 2
Most common and potential cyber threat vectors.
Figure 3
Figure 3
Scientific, validation, and operational considerations for wearable device implementation in clinical trials.

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