Biomarkers for Cardiovascular Drug Development: JACC State-of-the-Art Review - PubMed
3 months ago
- #cardiovascular drug development
- #biomarkers
- #clinical trials
- Biomarkers are crucial for cardiovascular, kidney, and metabolic drug development, aiding in diagnosis, risk stratification, and safety monitoring.
- Few biomarkers significantly influence trial design or regulatory decisions, with even fewer meeting surrogate endpoint criteria.
- A context-of-use framework is proposed, assessing biomarkers through analytical readiness and clinical/statistical validation.
- The review highlights the importance of preanalytical, analytical, and postanalytical variability in biomarker assessment.
- Discordance between biological plausibility and treatment-induced changes is noted, with examples like albuminuria and natriuretic peptides.
- Biomarkers can guide dose selection, enrich populations, and support adaptive design decisions in clinical trials.
- Regulatory perspectives from major agencies are summarized, with examples of successful and unsuccessful biomarker uses.
- Practical barriers include analytical variability, operational burden, and limited commercial incentives.
- Proposed solutions include standardized assays, harmonized data standards, open access platforms, and cross-trial biobanks.