Wearables in Clinical Trials: Exciting Developments and Lingering Concerns

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The use of wearable devices has skyrocketed over the past few years, with approximately 21% of Americans reporting regular use of a smart watch or wearable fitness tracker. Wearables are a great source of health-related data, which can even be streamed remotely in real time. Nowadays, smart wearable devices incorporate more sensors than ever – heart rate, oxygen saturation, even electrocardiograms, along with fitness and sleep information. Their potential advantages in clinical trial settings have not gone unnoticed. According to clinicaltrials.gov, there are approximately 950 trials that are using wearable devices, with over 300 of them successfully completed. However, this still only accounts for <2% of all trials, even though more studies could potentially benefit from their use.

One of the biggest issues in clinical trials is patient adherence to protocol, especially when there is extensive data collection required at home. This can be very demanding for participants and may discourage participation. Wearables can serve two roles in that domain, by delivering medication reminders and by collecting information in a continuous manner without the patient’s input. Importantly, since a large portion of the study can be conducted in the comfort of the participant’s home, this should lower participant dropout rates.

Wearable devices offer clear advantages in terms of data quantity and quality. Clinical trials are often conducted across different centers, sometimes spanning multiple continents. The use of the same wearable device type across sites will help with data consistency regardless of geographic location, especially if proper device usage training is provided. At-home data collection is also highly beneficial to researchers, since it results in real-life numbers that are consistent with the patients’ everyday activities. Furthermore, the increasing use of artificial intelligence (AI) in clinical trial data analysis will facilitate important pattern detection in large datasets collected from these devices.

Despite the large growth in wearable incorporation in clinical trials, there are still some legitimate concerns regarding regulations. The Clinical Trials Transformation Initiative has an extensive set of recommendations for the use of mobile technologies in clinical trials. They emphasize that devices themselves do not need to be approved by the Food and Drug Administration (FDA) to be used in clinical trials, but they do need to “verify and validate the appropriateness of the selected mobile technology.” The main problem here lies with the proprietary nature of the algorithms that these devices use, which may not allow researchers to thoroughly assess the accuracy of their sensors. In addition, many wearable manufacturers do not allow direct access to the raw data and give “black box” descriptions of the acquisition method and processing that takes place. The lack of data standards will likely slow the adoption of such devices in clinical trials.

Another issue regarding wearable use in clinical trials has to do with data ownership. All patient data collected during clinical trials fall under the Health Insurance Portability and Accountability Act (HIPAA), which regulates how protected health information can be used and shared. Consumer-grade devices are not regulated in the same way as medical devices, therefore many of the rules governing data protection are up to the manufacturers. Although many wearable manufacturing companies are working to support HIPAA compliance, there are still various privacy and data security concerns.

The innovation and potential that accompanies the use of wearables in clinical research is undeniable. However, there is still room for improvement to ensure a safe and reliable incorporation that benefits scientists, patients and society as a whole. Since this field is still fairly new, we can expect some drastic developments in the immediate future.

—  Vicky Kanta