ArticleDigital biomarkers
Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST.
Article in Digital biomarkers. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
8 citing papers in PubMed.
- Privacy-Aware Synthetic Tabular Data Generation for Healthcare: Application to Sepsis Detection.Bioengineering (Basel, Switzerland) · 2026Article
- Healthcare professionals' perspectives on digital biomarkers for monitoring inflammatory arthritis: insights from a qualitative study rooted in design thinking.EULAR rheumatology open · 2026Article
- PARKA AI: A Sensor-Integrated Mobile Application for Parkinson's Disease Monitoring and Self-Management.Bioengineering (Basel, Switzerland) · 2025Article
- Association of real life postural transitions kinematics with fatigue in neurodegenerative and immune diseases.NPJ digital medicine · 2025Article
- Aligning with regulatory agencies for the use of digital health technologies in drug development: a case study from Parkinson's disease.Frontiers in digital health · 2025Review
- Insights into Early Interactions on Innovative Developments with European Regulators.Therapeutic innovation & regulatory science · 2024Article
- Patient-centricity in digital measure development: co-evolution of best practice and regulatory guidance.NPJ digital medicine · 2024Review
- Article
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Innovative Medicines Initiative (IMI) consortium IDEA-FAST is developing novel digital measures of fatigue, sleep quality, and impact of sleep disturbances for neurodegenerative diseases and immune-mediated inflammatory diseases. In 2022, the consortium met with the European Medicines Agency (EMA) to receive advice on its plans for regulatory qualification of the measures. This viewpoint reviews the IDEA-FAST perspective on developing digital measures for multiple diseases and the advice provided by the EMA. Summary: The EMA considered a cross-disease measure an interesting and arguably feasible concept. Developers should account for the need for a strong rationale that the clinical features to be measured are similar across diseases. In addition, they may expect increased complexity of study design, challenges when managing differences within and between disease populations, and the need for validation in both heterogeneous and homogeneous populations. Key Messages: EMA highlighted the challenges teams may encounter when developing a cross-disease measure, though benefits potentially include reduced resources for the technology developer and health authority, faster access to innovation across different therapeutic fields, and feasibility of cross-disease comparisons. The insights included here can be used by project teams to guide them in the development of cross-disease digital measures intended for regulatory qualification.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.