The Respiratory Digital Measures Mission is a collaborative, precompetitive effort led by DEEP Measures to generate foundational, structured evidence in support of regulatory‑ready digital measures for respiratory conditions, with an initial focus on COPD and non‑CF bronchiectasis.
Mission Objective
The mission aims to define measurement concepts and device agnostic solution standards to support early regulatory feedback from FDA and EMA, with particular emphasis on digital approaches to tracking and monitoring cough‑related and other respiratory symptoms as potential primary or supportive endpoints.
Why This Mission
Digital measurement technologies are increasingly used in respiratory drug development, yet inconsistent definitions, variable methodologies, and limited consensus around fit‑for‑purpose solutions have slowed regulatory confidence and cross study comparability.
This mission addresses a critical opportunity to align early on what should be measured, how it should be measured, and how digital solutions can be evaluated independent of specific devices, enabling more confident and consistent engagement with regulators and accelerating adoption across programs.
Mission Scope
Indications
Focus areas
Exclusions
Mission Approach
The mission will be executed through a structured, stepwise process within the DEEP platform:
Step 1 – Measurement Definitions (MDs)
Conduct a targeted qualitative literature review to develop conceptual models centered on relevant Meaningful Aspects of Health (MAHs), Concepts of Interest (COIs), and candidate digital outcome measures for capturing respiratory symptoms in COPD and non‑CF bronchiectasis. These models will be refined and aligned to specific Contexts of Use (COUs) and drug targets.
Step 2 – Target Solution Profiles (TSPs)
Develop device agnostic Target Solution Profiles that define measurement requirements and inform solution selection criteria, building directly on the Measurement Definitions established in Step 1.
Step 3A – Digital Measurement Solutions (DMS)
Conduct technology landscaping to identify and evaluate fit‑for‑purpose Digital Measurement Solutions capable of capturing the defined measurement concepts and satisfying the TSP requirements.
Step 3B – Early Regulatory Engagement (FDA/EMA)
In parallel with Step 3A, plan and execute early regulatory interactions to obtain feedback on the proposed Measurement Definitions and Target Solution Profiles, informing future digital measure development strategies.
Expected Outcomes
Engagement Model
This mission is designed as a pre‑competitive collaboration among participating sponsors. Outputs generated through the mission are intended to inform both shared industry understanding and individual sponsor programs
Indicative Timeline
The mission is expected to span approximately 9 months, with staggered activities across measurement definition, solution profiling, technology landscaping, and regulatory engagement.
Interested in co-creating digital measures for respiratory conditions? Contact us to find out more about this mission.