Findings
The glossary establishes consistent terminology for digital health technologies, improving clarity in clinical research.
Definitions cover key aspects of digital measurement, including accuracy, precision, and validation.
Data integrity, security, and authentication are emphasized, particularly regarding structured and real-time data.
The glossary distinguishes between raw and processed data, providing clarity on data attribution and authenticity.
It includes terms relevant to both consumer-grade and regulated medical devices, supporting their appropriate use in clinical trials.
sDHT Adoption Navigator
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1. Why digital?
Explore the 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 a 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.
4. Your validation strategy
Introduces the V3+ framework and the four evidence domains required to demonstrate that an sDHT is fit-for-purpose for its intended context of use.
5. Operationalize your tech
Provides best practices for integrating sDHTs into clinical trials, balancing technical reliability with participant support and data-driven risk mitigation.
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.