Potential of Wearable Devices for Adverse Event Monitoring in Clinical Trials
​[Posted on: Thursday, February 09, 2017]

Adverse event monitoring in clinical trials can be automated and revolutionized using wearable medical devices as indicated by a recent study. The study showed that data collected using wearable devices to monitor physiological changes can be exploited to identify illness and other changes in health status over time. There are no surprises here but this is one of the few systematic studies to confirm what is widely claimed. Most consumers use wearable devices primarily for fitness tracking but as new devices are designed to track a host of physiological data such as heart rate, skin temperature, and blood oxygen levels. Such data is of limited use to an average consumer and even to a general physician but could be invaluable to clinical research professionals. Physiological changes indicative of adverse events could provide robust, timely and unbiased data to support the safety and even efficacy of a product in clinical trials and could be particularly useful for post-marketing pharmacovigilance. The key benefit of wearable devices is that the subjects can be monitored remotely giving high quality data with significant cost savings. There are several concerns with using wearable devices in clinical trials. Most of these concerns are due to lack of experience in employing such device for clinical trial data collection. But the sheer popularity of wearable devices coupled with inclusion of physiological monitoring in smart phones offer an incredible opportunity that should not be ignored. However, there are regulatory challenges with these devices. FDA does not regulated wearable devices used for tracking health information and hence most of the wearable devices do not have validation data required for using them in clinical trials. Sponsors will need to validate a given device to use it in the clinical trial. The diversity of the devices available increases the challenge for selection of the most suitable device. Many trials rely on bring-your-own-device (BYOD) concept to allow patients to use their own devices to increase compliance. However, that means that the sponsor will need to validate all the different devices being employed in their trial making it impractical. Using multiple distinct devices also makes it harder to combine data from all the devices used. Wearable devices are relatively new technology which is evolving rapidly and have been used very sparingly in clinical trials. The potential of adverse event monitoring should make it an attractive option.