Is the Use of Wearable Devices in Clinical Trials Over-Hyped?

Wearable devices such as smart watches, fitness devices, smart phones and mobile phone apps, and other such gadgets can be used to collect useful health-related information about the individual using them. It is often thought that using such devices one can track important clinical trial information and increase accuracy, speed and reliability of data. Recently, industry analysts projected that use of wearable devices could increase 4 folds in the next 4 years (from about $5 billion to almost $19 billion by the year 2020). The report went on to claim that wearable devices could boost patient recruitment, therapeutic outcome and clinical trial efficiency. However, the projection seems to be based on the assumption that most clinical trials could benefit from the kind of information collected by wearable devices which is not true. The most common information captured by wearable devices is about the general health of the user such a heart rate, blood pressure, body temperature, and some other simple vital functions. Most clinical trials do not require constant monitoring of such data. Another important use of wearable devices could be reminding for medications and diaries to collect information specific to a given clinical trial called patient reported outcomes (PRO). Although many studies collect PRO, very few studies rely only on PROs. So far FDA has taken a hands-off approach to wearable devices assuming that these devices at most collect low risk information. Use of such devices in clinical trials, particularly for health monitoring functions aimed to make safety claims about a given product, could raise concerns about the reliability of such information and hence the regulatory burden to show to FDA that wearable devices are still low risk. Wearable devices have a come a long way but concerns have been raised about their reliability. Standardization of measurement and validation of wearable devices need a lot of work. Most software used in wearable devices has not been validated per FDA’s standards and doing such will add to the cost and time for developing such devices for use in specific medical settings such as clinical trials. Device to device variability could lead to challenges with data analysis. The most useful application of wearable devices seems to be to communicate real-time with the clinical trial participants. That is useful but clinical trials have not really needed such communication and it is not clear if it is worth the effort. Although the use of wearable devices will certainly increase in the near future, the actual growth numbers may be lot more modest.