Pharma has spent years generating evidence for digital measures - yet much of it sits unused, scattered across public‑private partnerships and legacy research. What if the key to accelerating regulatory acceptance was already hiding in plain sight? This article reveals how DEEP Measures and a cross‑pharma consortium unlocked that dormant evidence, transforming it into regulatory‑ready digital measures and a roadmap for future clinical trials.
The Challenge
Pharmaceutical companies face significant challenges in meeting regulatory requirements for the adoption of novel digital measures in clinical research. Although much of the necessary evidence exists through public-private partnerships, it remains underutilized. EPFIA approached DEEP Measures to determine if evidence from legacy IMI (Innovative Medicines Initiative) and IHI (Innovative Health Initiative) projects could drive use and sustainability of the available evidence base.
The Approach
DEEP Measures formed a consortium with three leading pharmaceutical companies to address shared needs across four therapeutic areas:
- Develop regulatory-ready digital measures
- Identify evidence gaps
- Evaluate digital measure solutions
- Formulate regulatory acceptance strategies
The Foundational Content Consolidation initiative leveraged the DEEP Stack model, a structured framework for organizing and assessing digital measures. Key activities included:
- Systematic aggregation of literature and data from IMI/IHI projects (e.g., Mobilise-D, IDEA-FAST, PROactive, RADAR-AD) and public sources such as C-Path and DiMe
- Consolidation of digital measure definitions and concepts of interest (COIs) across domains like physical activity, limb mobility, fatigue, sleep, cognition, speech, and respiration
- Regulatory-readiness assessments, including validation, gap analysis, and risk mitigation
- The DEEP platform served as a central repository, enabling efficient cataloging, searching, and reuse of evidence, and facilitating the identification of evidence gaps
Impact
To date, the Foundational Content Consolidation initiative has completed evaluation of digital measures in physical activity, sleep, speech and cognition across multiple therapeutic areas. Key outcomes so far.
- Five measure definitions and six Target Solution Profiles (TSPs), standards and technical requirements for digital measurement solutions derived from public content.
- Mapping of digital measures for three indications, with Concepts of Interest (COI) in physical activity (activities of daily living, exercise tolerance), in sleep (respiratory difficulties, sleep impairment), and in speech/cognition (executive function, memory).
- Comparison of solution requirements, or Target Solution Profiles, to gold standards and evaluated for risks and potential for advancement based on existing evidence risk.
- Defined evidence generation requirements and regulatory strategy based on regulatory gap assessment.
The Foundational Content Consolidation initiative charts a roadmap towards utilization of digital measures in each of the selected domains in future clinical trials. This work now sets the stage for further consortia collaboration on harmonization and regulatory interaction to advance these measures. Additionally, non-confidential components of the work are currently being published to the DEEP public catalog so that they can be used by other members of the DEEP member community.
Key Learnings
- Early stakeholder engagement and evidence curation are essential for developing meaningful digital measures
- Collaborative consortia drive harmonization and standardization of measurement concepts and terminology
- A systematic, structured approach - supported by the DEEP platform - enables effective cross-functional collaboration.
Call to Action
If you’re interested in learning more about this initiative and how your organization may be able to participate in similar work, contact us to setup a meeting.
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