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Wearables Assessed for Clinical Trial Value

Smart watch

(Oliur Rahman, Pexels)

5 Feb. 2019. An evaluation of wearable devices shows their value for collecting useful data in a clinical trial can vary depending on the purpose of the device. A team from clinical research software company Koneksa Health Inc. in New York and Takeda Pharmaceuticals in Cambridge, Massachusetts reported their findings in the January 2019 issue of the journal Clinical and Translational Science.

The researchers from Takeda and Koneksa are seeking to determine the usefulness of wearable devices for providing the typical data collected on an individual’s vital signs, sleep, and activity gathered by clinical trial study teams. In nearly all circumstances today, trial participants need to travel to medical centers or clinics, where trained staff measure individuals’ heart rate and pulse, or periodically record vital signs data at home and fill out online forms. Wearable devices offer an easier way of collecting more data and more frequently.

A key decision is selecting an appropriate device for data collection in a clinical trial. Koneksa develops software for clinical trials that collect data from wearable devices and other sensors and devices used by trial participants, then integrate and report the findings. The company’s software supports mobile devices, as well as desktop systems for questionnaires and online forms. In November 2016, Koneksa and Takeda began a collaboration to integrate more data on vital signs, activity, and sleep patterns from wearables and sensors as data collection devices into clinical trials.

The journal paper is one result of that collaboration. In the study, 6 healthy volunteer participants in an early-stage drug-testing clinical trial agreed to wear two devices, a Phillips Actiwatch Spectrum Pro and Vitalconnect HealthPatch MD. Both devices are cleared by FDA as medical devices. The Actiwatch, worn on the wrist, collects data on activity and sleep patterns, while the HealthPatch includes a single-lead electrocardiogram worn on the chest and monitors heart rate, respiratory rate, and skin temperature. Participants then had these measures validated by conventional clinical equipment.

The results show the Actiwatch works well for recording activity and sleep pattern data, which also help interpret data on an individual’s vital signs. While the HealthPatch’s data on heart rate correlated with clinical measures, the device’s readings of respiratory rate and and skin temperature did not correlate with equivalent clinical equipment. In addition, the HealthPatch reported episodes of tachycardia, or rapid heart rate, attributed to voltage fluctuations that required intensive efforts by clinicians to resolve. The researchers recommend that wearable devices used in clinical trials for data collection should first be verified as feasible for their intended purpose before deployment.

“This paper is one of the first steps towards adopting wearable technologies in clinical development to bring much-needed medications to patients,” says Koneksa’s chief scientist and project leader Elena Izmailova in a company statement. “It’s one of a few publications that study wearable sensors in a real-world environment for the purposes of drug development, highlighting the benefits, as well as the challenges, of collecting wearable sensor data.” At the time of the study, Izmailova was a director of Takeda’s Data Science Institute.

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