Real-Time Monitoring Of The Digital Patient

Direct to patient strategies and crafting patient centric trials are of increasing interest in drug development trials. Wearables and sensors are seen as key enablers of this strategy. In order to assess the feasibility of collecting and integrating data from a number of different devices we undertook a proof of concept study, the results of which we presented in a poster entitled Real-Time Monitoring of the Digital Patient in Clinical Trials (DIA USA 2016). This poster reports on a framework for the real-time monitoring of subjects using wearable and patient-centric devices from multiple vendors.

The sustainability of the current clinical trial design process has been under scrutiny for a number of years. A 2014 paper commissioned by the US Department of Health and Human Services identified multifactorial barriers to drug development with patient retention and recruitment identified as significant contributors to the problem, and the report identified the wider use of lower-cost facilities, including at-home testing, as having multiple benefits, including increased trial participation [1].   

A number of recent innovations have created a digital health ecosystem that is facilitating the monitoring of patients in their home environment; the continued invested in mobile health (mHealth) by global health services, and a parallel explosion in the number of medical device grade, sensors that can measure a growing number of critical physiological indicators.

The shift of clinical assessment from the controlled environment of a trial site to the uncontrolled environment of a patient's home is a considerable challenge. The ability to authenticate source data while maintaining the anonymity and privacy of a patient offer considerable challenges. Connectivity and data security add additional complexity to the operations of remote studies.

The approach we explored was the creation of a suite of wearables that could be combined and deployed in a non-clinical setting and tailored to specific therapeutic areas, we refer to this as the Sensor Suite Approach.