Vascular biomarkers and surrogates in cardiovascular disease.
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.
Tardif
Jean-Claude
JC
Montreal Heart Institute, Université de Montréal, 5000 Belanger St, Montreal, H1T 1C8, Canada. jean-claude.tardif@icm-mhi.org
Heinonen
Therese
T
Orloff
David
D
Libby
Peter
P
D050197:Atherosclerosis / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D015415:Biomarkers; D002317:Cardiovascular Agents / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy*; D003952:Diagnostic Imaging / Q000379:methods / Q000639:trends; D017277:Drug Approval; D064420:Drug-Related Side Effects and Adverse Reactions; D023381:Endpoint Determination; D006801:Humans; D012307:Risk Factors; D014481:United States
D015415:Biomarkers; D002317:Cardiovascular Agents