In this free webinar, attendees will learn how new forms of DHTs are advancing chronic pain and neurological research. They will gain insight into how AI-enabled data management and remote monitoring enhance data quality and real-world evidence collection. The featured speakers will share strategies for improving patient-centered involvement, retention and cost efficiency in decentralized trials. The speakers will also discuss global trends in DHT adoption and how emerging technologies are shaping clinical outcomes.
TORONTO, April 15, 2025 /PRNewswire-PRWeb/ -- In response to the US government mandate to modernize clinical trials, the US Food and Drug Administration (FDA) introduced a "Framework for the Use of DHTs in Clinical Trials," defining digital health technologies (DHTs) as wearable, implantable, ingestible and environmental sensors integrated into software applications on mobile technologies. This framework has led to a mobile-first platform approach to direct data capture (DDC), which not only enhances healthcare management efficiencies but also personalizes remote patient participation in clinical trials.
Encouraged by the FDA's DHT guidance, the global rise in chronic pain and the rapid adoption of artificial intelligence (AI) analytics, a new generation of AI-empowered diagnostic devices is currently under 510(k) review and approval for use in the clinical research market.
This webinar will focus on the practical application of mobile-first platforms using embedded wearable diagnostic algorithms to measure objective endpoints in chronic pain and neurological disease within clinical studies. The frequent comorbidity between chronic pain and neurological disease can skew study outcomes as chronic pain often coexists with neurological conditions.
This overlap makes it challenging to isolate treatment effects on each condition using visual analog scale (VAS) and fit-for-purpose electronic clinical outcome assessment (eCOA) tools. New diagnostic devices address this challenge by combining subjective data capture with objective DDC, helping identify bias when detecting significant treatment changes compared to baseline.
These innovative diagnostic devices leverage wearable textile sensors that collect electrical, optical, thermal and cellular signals through minimally invasive methods, transmitting endpoints directly to mobile DHTs or indirectly via wearable transmitters. The integration of patient-centric metrics within smartphone apps enhances patient engagement and retention, supporting eCOA and electronic patient-reported outcome (ePRO) measurements alongside diagnostic data from chronic pain and neurological assessments in both responsive and non-responsive patients.
The evolution of DHT devices extends beyond improved patient experience and enhanced data capture. These devices also feed data into clinical data lakes, enabling AI-powered big data analytics and targeted machine learning to accelerate drug and device research and development. These innovations represent a shift away from traditional reliance on clinician assessments and self-reported data, providing a richer, more objective foundation for clinical diagnosis and monitoring.
In summary, the combined impact of clinical science and new DHT technologies offers a natural next step toward improved diagnostics and monitoring of chronic pain, neurological diseases and psychiatric conditions, including Parkinson's disease, dementia, Alzheimer's disease, schizophrenia, autism spectrum disorder, depression, epilepsy and stroke prognosis. The adoption of DHTs also addresses the need for cost-saving direct data capture, efficient data management and real-time analysis, helping reduce interpretation bias, white-coat anxiety and detachment from clinical sites — all while easing burdens on both patients and healthcare providers. This panel brings together industry experts from Crucial Data Solutions, BioTraceIT Ltd., and Firefly Neuroscience for an informative review and engaging discussion.
Register for this insightful webinar to explore how DHTs and AI analytics are reshaping clinical research for chronic pain and neurological conditions. Register today to secure your spot!
Join Jim Bob Ward, CEO, Crucial Data Solutions; Paul Grady, Founder, Crucial Data Solutions; Katie Hickey, Global Clinical Program Director, BioTraceIT Ltd.; and Gil Issachar, Chief Technology Officer, Firefly Neuroscience, for the live webinar on Wednesday, May 7, 2025, at 1pm EDT (10am PDT).
For more information, or to register for this event, visit The Future of AI Analytics on Chronic Pain and Neurological DHTs in Clinical Research.
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