Unlocking The Promise of Digital Health Technologies In Clinical Trials

Digital health technologies are reshaping how clinical trials are designed, measured, and executed — but progress has not kept pace with their potential. This webinar explores why the field remains at an inflection point and what it will take to move from promise to real-world impact. Experts from across the clinical research ecosystem examine the scientific, regulatory, and operational barriers that continue to slow adoption, including unclear evidentiary expectations, workflow challenges, and the limited number of qualified digital endpoints.

The discussion highlights how evolving FDA and EMA guidance now provides clearer expectations — particularly around patient-focused endpoint development and the stringent validation required for devices, algorithms, and data quality. Speakers also underscore the importance of patient-centered design, showing how meaningful concepts of interest must drive technology choices, not the other way around.

Attendees will gain insights into modular development strategies, emerging best practices for validation, and the growing need for alignment on terminology across digital endpoints, biomarkers, and COAs. With the field nearing a tipping point, this session offers a grounded, pragmatic look at the steps needed to accelerate confident, evidence-based adoption of DHTs in clinical research.