Wearable DHT 101: Foundations For Use In Regulated Clinical Trials

By Christine Guo, Ph.D.

Innovation in the life sciences, particularly within clinical trials, is an exciting yet challenging endeavor. As technology advances and regulations evolve, collaboration on shared terminology and best practices becomes essential to fully realize the potential of these innovations. This need for dialogue was a key motivator for launching our Digital Health Monthly webinar series. In the June 2024 session, we focused on key considerations for deploying digital health technology (DHT) in clinical research, sharing our experiences to contribute to the effective use of DHTs in clinical trials. By doing so, we aim to help accelerate the delivery of safer and more effective treatments to patients.

While DHTs can support a broad range of public health and clinical applications, our focus here is on wearable DHTs and their use as endpoints in regulated clinical trials. This discussion aims to connect the dots from technical specifications to regulatory acceptance, providing clinical trialists with a comprehensive view of the research and evidence generation journey that includes DHTs. In this blog post, we will delve into the benefits of continuous sensor data, the scope of wearable use in clinical trials, and the specific sensors and measures employed by wearable DHTs.