Abstract

Foundational Content Consolidation from Public-Private-Partnerships for Regulatory-Ready Digital Endpoints Across Multiple Therapeutic Areas. 

Research Objective(s)  

The Foundational Content Consolidation (FCC) initiative aims to develop regulatory-ready digital health endpoints by evaluating digital measures in key therapeutic areas, identifying evidence gaps, and formulating a strategy for regulatory acceptance. 

Methods  

DEEP Measures consolidates results from academia, public-private partnerships, and public sources to assess regulatory-readiness. It leverages the Innovative Health Initiative’s (IHI) In-Kind Additional Activities (IKAA) incentive, enabling industry companies to further develop results for their clinical needs in collaboration with pharmaceutical partners. Core activities include: 

• Systematic identification of relevant literature to consolidate digital measure definitions (MDs), meaningful aspects of health and concepts of interest (COIs) from legacy IHI projects (e.g., Mobilise-D, IDEA-FAST, RADAR-AD) and public sources. Focus on physical activity, sleep, cognition, and speech domains. Utilize the modular DEEP Stack model [Leyens et al, 2024] to structure content, identify gaps, and build reusable components and measures. 

• Regulatory-readiness maturity assessments for consolidated measures, focusing on validation, gap analysis, and risk mitigation.  

• Workshops with industry collaborators to integrate assets into targeted drug development programs.  

Outcome Measure(s)  

This project evaluated digital measures in physical activity, cognition, and speech domains across three therapeutic areas. The goal was to build novel MDs and Target Solution Profiles (TSP, standards and technical requirements for digital measurement solution) in collaboration with leading Pharma companies for use in future drug programs.  

Results  

Public content was consolidated, resulting in 5 MDs and 6 TSPs across selected domains. Digital measures were mapped for 3 indications across the neurological, metabolic, and respiratory therapeutic areas. In physical activity, COIs included variables of activities of daily living and exercise tolerance. In speech and cognition, they focused on executive function and memory. Developed TSPs were comparable to the gold standards. Companies accessed project workspaces on the DEEP Platform for real-time collaboration. Ongoing gap assessments will guide further evidence curation and regulatory strategy. 

Conclusion  

The FCC initiative showcases a scalable and collaborative approach to utilizing digital endpoints in drug development.  By consolidating digital measure content and assessing regulatory maturity across multiple disease areas, the project lays a foundation for regulatory acceptance and real-world adoption of novel digital endpoints in clinical trials. 

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