Biomarkers for Cardiovascular Drug Development: JACC State-of-the-Art Review
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A Aimo, J Butler, L De Michieli, G Mendieta, F Zannad…
JACC, 2026
Elsevier
Circulating and urinary laboratory biomarkers are central to cardiovascular, kidney, and metabolic drug development, and they support diagnosis, risk stratification, dose finding, safety monitoring, and, in selected settings, endpoint definition. Yet only a few materially shape trial design or regulatory decisions, and still fewer meet stringent criteria for surrogate endpoints. This review proposes a context-of-use framework in which circulating biomarkers are assessed along 2 converging “evidence lanes”: analytical readiness and clinical or …
