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Wearables and Decentralization

As decentralized clinical trials become more attractive in an era of COVID-19, the role of wearables in clinical research is beginning to have broad industry appeal. A new issue of Drug Development News brings together experts from industry and academia to discuss the evolving role of wearables in clinical research, including Dr. Natalia Muhlemann, Cytel’s VP of Strategic Consulting [1].

According to Natalia, wearables were beginning to play a far more valuable role in clinical trials, even before the pandemic, due to their ability to help sponsors support and contextualize patient experience. A part of this simply involves the way in which patients might respond to disorders on different days. For neurological disorders, for example, Natalia points out that most patients have good days and bad days. The state of a Parkinson’s patient during a visit to a clinic, for example, has randomness built into it which might not reflect all of these ups and downs over the course of say a week, or a month. A wearable device enables constant monitoring.

Natalia further observes that wearable devices enable clinical trial sponsors to recognize and contextualize patient reported outcomes in a manner previously not possible. “My threshold for pain is probably different from yours,” she observes, “My quality of life impairment is very different from my neighbor’s…”

The use of wearables enables sponsors to take these critical but subjective parameters, and make efforts to try and make them more objective.

There are challenges though, and through her recent Cytel Webinar Series on wearables, Natalia takes her audience through the complexities of constructing meaningful clinical endpoints, validating digitial biomarkers, and the other statistical and regulatory challenges that may arise in this burgeoning area of clinical trial design and delivery.

To learn more about the statistical, epidemiological and regulatory aspects of Wearables Clinical Trials, click below.

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Reference:

[1]: Special Report on Clinical Trials: Delving into decentralization