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(Circulation. 2006;113:2936-2942.)
© 2006 American Heart Association, Inc.

Special Report

Vascular Biomarkers and Surrogates in Cardiovascular Disease

Jean-Claude Tardif, MD; Therese Heinonen, DVM; David Orloff, MD; Peter Libby, MD

From the Montreal Heart Institute, Université de Montréal (J.-C.T., T.H.), Montreal, Canada; Brigham and Women’s Hospital (P.L.), Boston, Mass; and the United States Food and Drug Administration (D.O.), Rockville, Md.

Correspondence to Dr Jean-Claude Tardif, Montreal Heart Institute, 5000 Belanger St, Montreal, H1T 1C8, Canada. E-mail jean-claude.tardif{at}icm-mhi.org

Cardiovascular biomarker research efforts have resulted in the identification of new risk factors and novel drug targets, as well as the establishment of treatment guidelines. Government agencies, academic research institutions, diagnostic industries, and pharmaceutical companies all recognize the importance of biomarkers in advancing therapies to improve public health. In drug development, biomarkers are used to evaluate early signals of efficacy and safety, to select dose, and to identify the target population. The United States Food and Drug Administration has relied on biomarkers to support clinical applications in many therapeutic fields, including cardiovascular disease. The appropriate application of cardiovascular biomarkers requires an understanding of disease natural history, the mechanism of the intervention, and the characteristics and limitations of the biomarker. Channels of communication among researcher, developer, and regulator must remain open to maximize the success of future biomarker efforts. In 2003, 2004, and 2005, an international panel of cardiovascular biomarker experts convened at the "Cardiovascular Biomarker and Surrogate Endpoints Symposia" held in Bethesda, Md, to discuss the use of biomarkers in the development of improved cardiovascular diagnostics and therapeutics. The information presented in the present report summarizes the authors’ perspective distilled from these proceedings.

Key Words: cardiovascular diseases • coronary disease • diagnosis • imaging • prevention

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