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Wearable Devices in Clinical Trials: Hype and Hypothesis
Author(s) -
Izmailova Elena S.,
Wagner John A.,
Perakslis Eric D.
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.966
Subject(s) - wearable computer , context (archaeology) , clinical trial , wearable technology , computer science , maturity (psychological) , health technology , biopharmaceutical , health care , data science , risk analysis (engineering) , medicine , psychology , pathology , paleontology , developmental psychology , genetics , economics , biology , embedded system , economic growth
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.