Challenges and potential of using digital biomarkers in healthcare and clinical trials

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.