The Digital Health Measurement Collaborative Community (DATAcc) by the Digital Medicine Society (DiMe) has received a grant from the U.S. Food and Drug Administration (FDA) to develop a comprehensive "How-To Guide" for technology developers and life sciences companies. This guide aims to promote the use of sensor-based digital health technologies (sDHTs) in clinical trials to develop digitally-derived endpoints.
Addressing Industry Challenges with Digital Endpoints
The guide is a response to industry challenges in applying sDHTs for capturing digitally-derived endpoints in clinical research. While the science is established and the regulatory environment has matured, many developers and life science companies face obstacles in integrating these technologies into trials. Recent industry findings suggest that endpoints derived from DHTs can substantially reduce clinical trial timelines, improve ROI, and make trials more feasible in challenging markets.
Comprehensive and Interactive Resource
The "How-To Guide" will consolidate existing regulatory guidelines, scientific resources, and industry case studies into a one-stop resource for developers and clinical trial teams. It will simplify the process of selecting and using sensor-based digital health technologies, ensuring their efficacy and acceptance in regulatory submissions. The guide will be an interactive platform that allows life sciences professionals and sDHT developers to understand the steps required to generate high-quality evidence, select appropriate endpoints, and integrate these technologies into trials with confidence.
Key Features and Benefits
The guide will address specific market challenges by providing:
- A central, interactive hub compiling scientific knowledge, regulatory guidance, and practical examples.
- Clear instructions for selecting and validating digital endpoints, and for building sensor-based DHTs that meet market needs.
- Insights on how DHTs can reduce timelines, accelerate the introduction of therapies, and enhance diversity and inclusion in trials through more generalizable findings.
Supporting Faster and More Inclusive Trials
Jennifer Goldsack, CEO of DiMe, emphasized that the guide is not just consolidating science but creating a platform to improve ROI and reduce participant burden. The regulatory advancements and extensive case studies make this guide a critical tool for developers and researchers seeking to bring DHT-based products to market. DiMe also has ongoing projects like the pediatric rare disease initiative, aimed at defining high-quality digital measures to accelerate research and deliver therapies to children with rare diseases.
