The Future of AI Analytics on Chronic Pain and Neurological DHTs in Clinical Research

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. The proposed panel will bring together industry experts for an informative review and engaging discussion.

Join 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!

Speakers

Jim Bob Ward, CEO, Crucial Data Solutions

Jim Bob Ward is an internet pioneer, mathematical statistician and AI technology advocate with over 30 years of experience. He is the CEO of Crucial Data Solutions after leading Datatrak, ClickFind and Real Time. Jim Bob has been a guest speaker for global, national and regional events, including DIA China, DIA Europe, SCDM San Diego, US agencies, EU and World Bank across 12 countries.

His technology platforms have generated hundreds of millions of dollars and billions for partner users. Awards include Top 10 Pioneering Leaders Redefining Healthcare, Top 10 Best Clinical Trial Management Software Companies and Texas A&M University Chancellor’s Award in Research Excellence.

Message Presenter

Paul Grady, CTO, Crucial Data Solutions

Paul Grady brings innovation and disruptive change to the clinical trials landscape. Combining 30+ years’ experience in all aspects of clinical research technology, an entrepreneurial spirit and background as a web developer and database architect, Paul provides valuable insights and a unique perspective on the challenges of clinical trials. He started and successfully exited four other clinical technology companies: Summit Medical Systems; Acumen Healthcare Solutions LLC; Clinsights, Inc. and MedNet Solutions, Inc.

Message Presenter

Katie Hickey, Global Clinical Program Director, BioTraceIT Ltd.

Katie Hickey completed her BSc in Animal Science and her MSc in Reproductive Physiology at the University of Guelph, Canada. She has worked in academic research as well as an Operations Director, Researcher and Continuous Improvement Director in the animal production industry at Semex. At BioTraceIT, Katie brings animal health and clinical experience through her work in academics and industrial innovation, R&D, product development and global team management. Working with PainTrace in industry for many years, she understands the products in real-world use and can apply best practices with our clinical research clients that use PainTrace as a clinical research outcome measure.

Message Presenter

Gil Issachar, Chief Technology Officer, Firefly Neuroscience

Bio coming soon.

Message Presenter