@article{9a5dbe216a0747f8950d86bdac8475a8,
title = "Biomarker-guided therapies in heart failure: A forum for unified strategies",
abstract = "The complexity of standard medical treatment for heart failure is growing, and such therapy typically involves 5 or more different medications. Given these pressures, there is increasing interest in harnessing cardiovascular biomarkers for clinical application to more effectively guide diagnosis, risk stratification, and therapy. It may be possible to realize an era of personalized medicine for heart failure treatment in which therapy is optimized and costs are controlled. The direct mechanistic coupling of biologic processes and therapies achieved in cancer treatment remains elusive in heart failure. Recent clinical trials and meta-analyses of biomarkers in heart failure have produced conflicting evidence. In this article, which comprises a summary of discussions from the Global Cardiovascular Clinical Trialists Forum held in Paris, France, we offer a brief overview of the background and rationale for biomarker testing in heart failure, describe opportunities and challenges from a regulatory perspective, and summarize current positions from government agencies in the United States and European Union.",
keywords = "Pharmacogenetics, biologic markers, cardiovascular diseases, clinical trials",
author = "Mona Fiuzat and O'Connor, {Christopher M.} and Francois Gueyffier and Mascette, {Alice M.} and Geller, {Nancy L.} and Alexandre Mebazaa and Voors, {Adriaan A.} and Adams, {Kirkwood F.} and Pi{\~n}a, {Ileana L.} and Ludwig Neyses and Pieter Muntendam and Felker, {G. Michael} and Bertram Pitt and Faiez Zannad and Bristow, {Michael R.}",
note = "Funding Information: The National Heart, Lung, and Blood Institute (NHLBI) and the EU Research and Innovation Directorate General representatives presented goals and visions regarding personalized medicine. Notably, the alignment of these agencies is encouraging and may provide a framework for global collaborative efforts. The EU Framework Programme for Research and Technological Development has devoted a great portion of available funding to research in health initiatives. 71 Personalized medicine is one area identified as a priority for funding research, which would include the creation of networks among academic institutions, industry, regulatory agencies, patient representatives, and other stakeholders. Examples include the European Commission Seventh Framework Programme for Research (FP7) and projects such as Biostat-CHF ( www.biostat-chf.eu ) and Heart Omics in Ageing (HOMAGE). 72 To identify bottlenecks in progress and propose solutions for future activities, a number of workshops were organized, and a Personalized Medicine Conference was convened in May 2011. 73 Challenges identified included: 1) generating knowledge and developing the right tools; 2) translation to clinical applications; 3) breaking down barriers and speaking the same language; and 4) economic impact, with a need for studies and standard methodologies. The “time for action” in personalized medicine comes in the context of defining a common strategic framework for research and innovation activities: Horizon 2020. 74 The NHLBI vision of the development of personalized medicine is remarkably similar. The NHLBI Strategic Plan includes a mandate to develop personalized preventive and therapeutic regimens for cardiovascular conditions and lung and blood diseases. 75 Funded programs include research initiatives in systems biology, genomics, fundamental discoveries, and clinical applications. The nongovernmental Foundation for the National Institutes of Health supports the Biomarkers Consortium, a public-private partnership with multiple industry sponsors. The Consortium is designed to model biomarkers of atherosclerosis in an effort to facilitate development of new drugs that may have incremental therapeutic benefit in the era of widespread statin use. This type of a collaborative approach might also be applied in integrating biomarker data in HF. The NHLBI hosted working groups on personalized medicine and cardiovascular pharmacogenomics in 2011. 76,77 Participants recommended the inclusion of DNA collections in NHLBI-funded clinical trials, as is being done in the Heart Failure Clinical Research Network. Finally, dissemination and sharing of existing data, as is done for genetic data in the National Institutes of Health–funded Database of Genotypes and Phenotypes (dbGaP) 78 remain a crucial foundation for advancing our understanding of the personalized approach. ",
year = "2013",
month = aug,
doi = "10.1016/j.cardfail.2013.05.012",
language = "English (US)",
volume = "19",
pages = "592--599",
journal = "Journal of Cardiac Failure",
issn = "1071-9164",
publisher = "Churchill Livingstone",
number = "8",
}