Implementing Sensor-Based Digital Health Technologies in Clinical Trials

This technical report discusses the implementation of sensor-based digital health technologies (DHTs) in clinical trials, focusing on key considerations identified by the Electronic Clinical Outcome Assessment (eCOA) Consortium. The report outlines the challenges and concerns associated with DHT deployment, particularly regarding participant compliance and the potential burden on trial participants. It emphasizes the importance of selecting a relevant clinical concept of interest and defining appropriate digital measures to enhance participant engagement. The document also details the process of DHT implementation, which includes considerations of data capture methods, participant training, and logistical factors that may affect compliance. Furthermore, it highlights the need for diversity and inclusion in clinical trials and the significance of sharing trial results with participants. The report aims to provide a comprehensive understanding of the factors influencing the successful integration of DHTs in clinical research, ultimately contributing to improved trial outcomes and participant experiences.