DEEP Measures
The comment as filed
About DEEP Measures
DEEP Measures accelerates the utilization of digitally derived measures by supporting pharmaceutical and biotech companies, technology developers, and academic institutions to collaborate on the creation, validation, and acceptance of digital endpoints derived from sensor-based digital health technologies (DHTs) for use in clinical investigations. Our structured evidentiary framework and content model is designed to support the development of patient-focused, fit-for-purpose digital measures with appropriate definitions and evidence to enable regulatory qualification and utilization in clinical trials. In our work building structured evidence packages with sponsors, we have observed that the difficulty of assembling regulatory-ready DHT documentation often stems from the absence of a shared, modular content model, which creates the need for sponsors to recreate provenance documentation from scratch for each clinical program. To address this, DEEP Measures works with sponsors to enable reuse of structured, modular DHT evidence components, such as device configuration, analytical validation, usability evidence, and data capture and processing lineage, across clinical programs and DHT regulatory submissions to the FDA and EMA. Additionally, to further accelerate the digital health ecosystem, DEEP Measures leads an industry consortium of pharmaceutical companies, called the Global Advocacy Network (GAN), that works together to advance regulatory science and accelerate the adoption of harmonized digital measure solutions by actively shaping the regulatory and policy landscape for digital health technologies.