Cardio-oncology & otherResearch article

Biomarkers for Cardiovascular Drug Development

J Am Coll CardiolPublished

  • Narrative review

Main finding

As reported in the abstract

Context-of-use framework for circulating biomarkers in CV drug development
  • Biomarkers assessed along 2 converging evidence lanes: analytical readiness and clinical or statistical validation
  • Frequent discordance between biological plausibility or prognostic strength and treatment-induced changes that reliably predict clinical benefit (eg, albuminuria, natriuretic peptides, glycemic, inflammatory and lipid markers)
  • Only a few biomarkers materially shape trial design or regulatory decisions; still fewer meet stringent criteria for surrogate endpoints

Original publication

Biomarkers for Cardiovascular Drug Development. J Am Coll Cardiol. Published 11 February 2026. doi:10.1016/j.jacc.2025.12.072

Summarised from the published abstract; every number is checked against it