The Future Of AI Analytics On Chronic Pain And Neurological DHTs In Clinical Research

In response to the U.S. government’s push to modernize clinical trials, the FDA introduced a framework promoting the use of digital health technologies (DHTs), including wearable, ingestible, and environmental sensors integrated with mobile software. This guidance has spurred the adoption of mobile-first platforms for direct data capture (DDC), enhancing both healthcare efficiency and personalized, remote trial participation.

Amid growing global interest in managing chronic pain and neurological diseases—and with AI analytics advancing rapidly—a new wave of AI-enabled diagnostic devices is undergoing FDA 510(k) review for clinical research applications. These devices use embedded wearable algorithms to measure objective endpoints, addressing the limitations of subjective tools like visual analog scales (VAS) and electronic clinical outcome assessments (eCOAs), particularly when chronic pain overlaps with neurological conditions. This presentation, featuring experts from Crucial Data Solutions, BioTraceIT, and Firefly Neuroscience, explores how DHTs and AI-driven diagnostics are transforming clinical research, supporting more accurate assessments and accelerating therapeutic development in chronic pain and neurological disorders.