
Welcome to the sDHT Adoption Roadmap
The concise, end-to-end guide for implementing sensor-based digital health technologies (sDHTs) in medical product clinical trials. We distill best practices and guidance from the FDA and leading consortia, covering the full digital measure lifecycle.
1. Why digital?
Explore the compelling reasons to embrace sDHTs in clinical trials, beginning with patient-focused development that centers on capturing real-world data reflecting how patients truly feel, function, and live their lives, leading to more precise, inclusive, and meaningful outcomes.
Build your most compelling business case, demonstrating how adopting these technologies accelerates timelines, boosts ROI, enhances operational resilience, and differentiates your work through patient value.
2. Your core strategy
This section is about laying the foundation for success with your digital endpoint. The activities here—defining the context of use, aligning stakeholders, and bringing the right sDHT into the trial—rarely unfold in a tidy sequence. More often, they happen in parallel and from different starting points.
3. Engage regulators
This section explains how adopters and developers can navigate regulatory engagement opportunities to obtain input that reduces uncertainty in downstream development.
Whether you’re a developer seeking clarity on validation requirements or an adopter preparing for trial implementation, this stage equips you to engage regulators with a focused ask, supporting evidence, and a shared internal rationale.
5. Operationalize your tech
In this stage, discover best practices for integrating sDHTs into clinical trials, balancing technical reliability with participant support and regulatory compliance. Gain actionable insights into data management, risk mitigation, and monitoring to ensure high-quality evidence generation
6. Refine your strategy
In this section, explore comprehensive strategies for post-trial analysis, refinement, and knowledge dissemination to maximize the value of your sDHT deployment. Capture lessons from data, participants, and operations to inform internal iterations, while contributing to broader industry progress through sharing and collaboration.
Your co-pilot for the road ahead
This work takes time, but the Roadmap is designed to be your companion every step of the way.
You can save information and bookmark your progress. You may explore the content at your own pace and start wherever you like. If you are unsure where to begin, the AI-powered assistant can guide you to the appropriate starting point.