Challenges and potential of using digital biomarkers in healthcare and clinical trials
Abstract
Digital biomarkers use sensors and analytics, to offer continuous monitoring and personalized medicine. In this Perspective, we describe real-world use cases, such as glucose tracking to optimise insulin dosing and wearables to measure heart rhythms to de-risk cardiovascular trials. We also discuss the issues preventing most candidate biomarkers from reaching clinical practice. Evidence generation is costly, regulatory reviews can be redundant, commercial incentives fall short, and data silos can be biased and/or nonrepresentative. By combining harmonized qualification pathways, value-based reimbursement, modular extensions for single-trial biomarkers, and adaptive post-market evidence loops, we propose a path from experimental signal to standard of care.
Fields of Study & Subjects
Diabetes Management and Research
Mobile Health and mHealth Applications
Digital Mental Health Interventions
Publication details
- Journal / source
- Communications Medicine
- Publisher
- Springer Science and Business Media LLC
- Volume
- 6
- Issue
- 1
- Publication date
- 21 February 2026
- Language
- EN