FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Sensors and Wearables Transform Clinical Trials but Challenges Remain, Experts Say

March 8, 2018
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With a multitude of sensors, wearables and mobile devices becoming available for use in clinical trials, sponsors should conduct systematic comparisons before designing protocols, according to experts at the annual SCOPE conference, who presented the work they’ve done to demonstrate the value of using digital monitoring in their studies, as well as the obstacles they encountered.

Choosing the right device from the outset, in a patient-centric manner, can directly affect adherence and the eventual quality and consistency of the data — as well as on the back end, where certain product choices can cause technical headaches.

Many devices, available at different price points, can return raw data in various formats, with some possibly inappropriate for use in clinical research, said Bhaskar Dutta, principal scientist of AstraZeneca’s Advanced Analytics Center.

Some can log missing data as a zero, potentially mirroring an actual measurement — and others don’t track heart rates over 100 beats per minute, Dutta said. In addition, certain devices may only report data on a daily basis, or even report some data types every minute and others every four, causing issues in sampling and final analyses.

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