In an environment where patient safety is paramount and the integrity and quality of data is sacrosanct, it can be challenging to introduce new technologies since it is difficult for the regulatory authorities to keep up with the pace of changes, and issue new or revised guidelines that allow for, but provide guard rails for the use of innovations. One such area is the collection of patient outcomes and biomarkers via sensors or ‘wearables’.
In 2016, an estimated 300 studies included a mobile health device, that number has now grown to over 1000, but none are using the devices to support a primary safety or efficacy endpoint. There is hesitation around the use of connected sensors because there is no specific published guidance on the use of wearables to collect data to support endpoints in clinical studies. However existing guidance for the use of patient-reported outcome measures to support medical device labelling claims can be used to draw parallels . In addition, there is guidance on the use of medical devices in healthcare that outlines the FDA’s position on the use of wearables that could be considered ‘general wellness’ device .
There are also considerations for how patients are informed and consent to the collection of personal data, and data storage and data transmission/re-use implications, particularly in the European Union with the implementation of GDPR. Also, there are health economic and outcomes research factors that must be considered to ensure that the associated endpoints are fit for purpose for regulatory submissions.
In summary, this is an emerging exciting but challenging area of innovation in clinical trials where there is still a lot to learn. Join our discussion of the balancing act between innovation and compliance at HORIZONS 2018 Innovation Summit in Washington DC, October 15-17.
 Selection of and Evidentiary Considerations for Wearable Devices and Their Measurements for Use in Regulatory Decision Making: Recommendations from the ePRO Consortium
Byrom, Bill et al.
Value in Health , Volume 21 , Issue 6 , 631 – 639
 General Wellness: Policy for Low Risk Devices: Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed 22 August 2018
Regulatory Information Management (RIM)