Sensor-based digital health technologies (sDHTs) are poised to revolutionize drug and medical device development by enabling the measurement of previously inaccessible disease aspects. While there is significant promise in using sDHTs as drug development tools (DDTs) and medical device development tools (MDDTs), there is still uncertainty across the developer community and life sciences industry regarding the necessary evidence for regulatory acceptance.
To help unlock this potential, DATAcc by DiMe has been awarded a grant by the FDA to develop a “How-To Guide” for using sDHTs as digital endpoints in clinical trials. This guide builds on recent industry findings showing that endpoints derived from sDHTs can reduce clinical trial timelines, improve return on investment (ROI), and make trials more feasible in difficult markets.
Key features of the guide will address specific market challenges including:
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Comprehensive resource: A central, interactive hub that compiles scientific knowledge, regulatory guidance, and practical examples from across the industry. -
End-to-end process guidance: Clear recommendations for life science teams on selecting and validating digital endpoints, and for developers on building sensor-based sDHTs that will meet market needs.
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Support for faster, more inclusive trials: Insights on how sDHTs can reduce timelines, accelerate the introduction of life-saving therapies, and enhance diversity and inclusion in trials through more generalizable findings.
DiMe has several projects on the horizon to advance the use of digital health measures in research to improve lives. Join projects such as the Pediatric Rare Disease Digital Measures Development, a collaboration to define high-quality digital measures to accelerate research and deliver life-saving therapies to children with rare diseases around the world.
