Advanced Clinical Trials and Clinical Research

Digital Therapeutics Trials

Digital therapeutics (DTx) represent a novel class of evidence-based, software-driven treatments for medical conditions. This session explores the unique aspects of designing and executing clinical trials for DTx, including endpoints validation, digital biomarkers, and real-time patient interaction monitoring. Attendees will learn how to address specific regulatory requirements, such as those from the FDA’s Digital Health Center of Excellence, and how to ensure compliance with software-as-a-medical-device (SaMD) frameworks. The session also highlights how patient engagement platforms, gamification, and adherence tracking can improve outcomes in digital health interventions. Case studies from behavioral health, chronic disease management, and neurological disorders will be shared. Special emphasis will be placed on trial design methodologies that suit iterative software updates and continuous learning systems. Whether evaluating a standalone app or a combination product, this session equips participants with a roadmap to conduct robust and compliant DTx trials that align with both clinical and digital development standards.