1. Why digital?
Clinical trials can now capture the real rhythms of a patient’s life—the quiet moments at home, the daily challenges of mobility, or the subtle shifts in how someone feels from one day to the next.
This is the new reality of sensor-based digital health technologies, or sDHTs, which are reshaping how we understand health and treatment outcomes in medical product development.
In this section of the roadmap, we explore the compelling reasons to embrace sDHTs, starting with the heart of the matter: putting patients at the center of everything.
We start by anchoring our approach in patient-focused development—because solving real problems for real people drives everything forward.
DiMe’s CEO, Jennifer Goldsack, describes the critical role of digital endpoints in a complex and rapidly evolving environment.
A note on scope
This Roadmap is not intended to suggest that digital approaches should always replace or diminish the value of established nondigital assessments. Traditional clinical, functional, and patient-reported measures remain essential to medical product development and, in many cases, represent the most appropriate way to capture meaningful outcomes. The focus here on sensor-based digital health technologies reflects their growing role in enabling continuous, real-world, and patient-centered measurement, and the distinct scientific, operational, and regulatory considerations that accompany their use. The Roadmap is intended to support teams in understanding when and how digital endpoints can add value alongside existing assessment approaches.
SECTION 1 | WHY DIGITAL
Ready to dive in?
These subsections and resources will give you practical tips, best practices from the field, and point you to relevant sections of FDA guidances.
Explore why sDHTs matter in clinical trials by capturing real-world data on how patients truly feel, function, and live, leading to more precise, inclusive, and meaningful outcomes.
Build your business case by demonstrating how adopting these technologies accelerates timelines, boosts ROI, enhances operational resilience, and differentiates your work through patient value.