DATAcc by DiMe Awarded FDA Grant to Boost Use of Sensor-Based Digital Health Technologies in Clinical Trials

DATAcc is creating an open-source industry guide to address market challenges by bringing clarity on how and why to include digital endpoints in clinical trials

BOSTON, Oct. 3, 2024 /PRNewswire/ — Today, the Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is excited to announce it has been awarded a grant from the U.S. Food and Drug Administration (FDA) to develop a comprehensive “How-To Guide” for technology developers and the life sciences seeking to advance the broad use of sensor-based digital health technologies (sDHTs) to develop digitally-derived endpoints in clinical trials.

This guide builds on recent industry findings that endpoints derived from DHTs can substantially reduce clinical trial timelines, improve ROI, and make trials more feasible in challenging markets. It’s designed to capitalize on that potential, offering the life sciences community a clear pathway to navigate the complex landscape of digital endpoints and accelerate the path to market for life-saving therapies. As a result, driving substantial returns on investment (ROI) in clinical trials, reducing participant burden in clinical trials, and improving the relevance of the data captured for scientific and clinical decision making.

The guide is being created in response to industry challenges surrounding the application of sDHTs to capture digitally-derived endpoints in clinical research. While the science behind these technologies is well-established and the regulatory environment has matured, many developers and life science companies still face significant obstacles in successfully  integrating these technologies into trials.

The new “How-To Guide” will synthesize existing regulatory guidelines, scientific resources, and a wide array of industry case studies to provide a one-stop resource for developers and clinical trial teams alike. It will demystify the process of selecting and using sensor-based digital health technologies, ensuring their efficacy and acceptance in regulatory submissions.

“We’re not just consolidating all of the science,” said Jennifer Goldsack, CEO of DiMe. “We’re creating an interactive platform that will allow life sciences professionals and sDHT developers to clearly understand the steps required to generate high-quality evidence, select appropriate endpoints, and integrate these technologies into trials with confidence to improve ROI while reducing participant burden.”

Key features of the guide will address specific market challenges including:

• 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 instructions for life science teams on selecting and validating digital endpoints, and for developers on building sensor-based DHTs that will meet market needs.
• Support for faster, more inclusive trials: Insights on how DHTs can reduce timelines, accelerate the introduction of life-saving therapies, and enhance diversity and inclusion in trials through more generalizable findings.

The regulatory advancements we’ve seen to date, along with the extensive case studies drawn from across the industry, make this guide a critical tool for developers and researchers seeking to bring DHT-based products to market.

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 initiative, a collaboration to define high-quality digital measures to accelerate research and deliver life-saving therapies to children with rare diseases around the world.

About the Digital Medicine Society: DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.

About DATAcc by DiMe: The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) is a collaborative community with the FDA’s Center for Devices and Radiological Health. We provide a forum for collaboration where partners and experts from across the digital health field work to advance the use of digital health measures in research to improve lives.

Media Contact: Carla English, press@dimesociety.org 

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SOURCE Digital Medicine Society (DiMe)