Wearable Devices in Clinical Trials: Hype and Hypothesis.

Journal Article (Journal Article;Review)

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.

Full Text

Duke Authors

Cited Authors

  • Izmailova, ES; Wagner, JA; Perakslis, ED

Published Date

  • July 2018

Published In

Volume / Issue

  • 104 / 1

Start / End Page

  • 42 - 52

PubMed ID

  • 29205294

Pubmed Central ID

  • PMC6032822

Electronic International Standard Serial Number (EISSN)

  • 1532-6535

Digital Object Identifier (DOI)

  • 10.1002/cpt.966


  • eng

Conference Location

  • United States