Accelerating the Path to Approval: Validating Novel Digital Clinical Measures
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Novel digital measures offer a huge potential to capture meaningful aspects of health in ways that have been previously impossible to assess. These measures can capture new concepts that focus on how a patient feels, functions, or behaves and can capture them in real-world environments at a significantly increased frequency without clinician supervision.
However, the increasing adoption of these novel digital measures is limited by a gap in the clinical and regulatory science underpinning their validation. By addressing these gaps, we’re establishing a stronger evidence base for digital health tools, making it easier for regulators, payors, and clinicians to adopt these technologies confidently.
DATAcc by DiMe, along with a multi-stakeholder group of statistical experts, digital health technology pioneers, and regulatory colleagues, developed a new framework and interactive platform to simplify and standardize the statistical evaluation of DHTs. These new resources validate novel digital clinical measures, establish systematic criteria for selecting suitable reference measures for new digital clinical measures, and evaluate their performance requirements.
Join us to learn more about the framework and simulation toolkit and how they can support your work in validating and developing novel digital clinical measures.
