Author: Michael A. Pacanowski, PharmD, MPH on February 08, 2019
Consumer-oriented wearable devices, which commonly take the form of a wristwatch, have allowed us to quantify our daily movements with fine detail, and even examine the quality of our sleep. But beyond our personal, health-oriented curiosities, wearable devices and the related digital readouts have shown great promise in augmenting how we characterize health, disease, and drug response.
Clinical trial assessments of drug efficacy or safety often rely on discrete, controlled measurements at some specified time interval and might not provide a global picture of an individual’s state of health over time. Use of wearable devices in clinical trials could allow investigators to obtain additional data in a real-world setting, or collect physiological measurements or other patient information remotely to reduce the need for clinic visits. In theory, the potential exists for this technology to make clinical trials more sensitive to detecting a drug’s benefits and risks, and more efficient.
While the possibilities are exciting and seemingly endless for the use of wearables to study many diseases and conditions, it is still necessary to evaluate whether and how to adopt their use, as would be the case for any new technology. For instance, there may be challenges with comparisons between patients in different environments. Also, it is important to clearly define the parameters of what information will be collected and for what purpose.
In a study recently published in Clinical and Translational Science, Izmailova, et al., report on the results of a pilot study that evaluated the use of two wearable devices to monitor subjects in a phase I trial context. For the most part, this effort was successful, though several important challenges surfaced. The investigators found that artefactual deviations in some measurements like heart rate resulted in the need for manual verification, the lack of real-time access to data limited the device’s utility in identifying acute safety issues, and lack of adherence can result in periods of missing data (because devices only collect data when worn). Notwithstanding the challenges, this study demonstrated the feasibility of deploying such technologies in a small-scale clinical trial, and the investigators provide several learnings and insights from the experience. Read the full article today!
Disclaimer: This publication reflects the views of the author and should not be construed to represent FDA’s views or policies.
Image by Izmailova, et al.. Clin. Trans. Sci., https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12602, is licensed under CC BY-NC 4.0. ©2018 The authors.
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