Digital Technology in Clinical Trials

With the ever expanding availability and capability of both medical and commercial-grade wearable devices and mobile sensors there has been a corresponding growth in interest in including them in clinical trials to collect data to provide additional insight into patient experience. However, while these technologies can measure a wide range of physical and biologic variables, their use can sometimes have the appearance of a solution in search of a problem. Extending the idea of “content validity” from the patient-reported outcome measure developmental literature, identifying what one is measuring with a sensor and, most importantly, what this means to the patient using it, is a vital step that is currently not fully appreciated within the pharmaceutical, sensor, and medical device industry.

This session will provide attendees guidance on how to establish content validity for mobile sensors and wearables and the importance of clearly defined ‘concepts of interest’ for establishing clinical trial endpoints. Firstly, a case study in chronic heart failure, where in depth work is being done with patients to identify meaningful outcomes that can be measured by a wearable device; secondly, a discussion of some of the lessons that can be learned from performance outcome (PerfO) assessments, where similar challenges in demonstrating content validity and identifying appropriate individual change metrics are present; and finally, an outline of how the industry can ensure the intentional development of these tools, which have so much potential, to properly integrate the patient experience in clinical trials in the future. Developing meaningful measures from wearable/mobile sensor technology is the necessary foundation to their use to derive clinical trial endpoints that are meaningful assessments of clinical benefit.