Charting a roadmap for heart failure biomarker studies
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Charting a roadmap for heart failure biomarker studies. / Ahmad, Tariq; Fiuzat, Mona; Pencina, Michael J; Geller, Nancy L; Zannad, Faiez; Cleland, John G F; Snider, James V; Blankenberg, Stephan; Adams, Kirkwood F; Redberg, Rita F; Kim, Jae B; Mascette, Alice; Mentz, Robert J; O'Connor, Christopher M; Felker, G Michael; Januzzi, James L.
In: JACC-HEART FAIL, Vol. 2, No. 5, 10.2014, p. 477-488.Research output: SCORING: Contribution to journal › SCORING: Review article › Research
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TY - JOUR
T1 - Charting a roadmap for heart failure biomarker studies
AU - Ahmad, Tariq
AU - Fiuzat, Mona
AU - Pencina, Michael J
AU - Geller, Nancy L
AU - Zannad, Faiez
AU - Cleland, John G F
AU - Snider, James V
AU - Blankenberg, Stephan
AU - Adams, Kirkwood F
AU - Redberg, Rita F
AU - Kim, Jae B
AU - Mascette, Alice
AU - Mentz, Robert J
AU - O'Connor, Christopher M
AU - Felker, G Michael
AU - Januzzi, James L
N1 - Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PY - 2014/10
Y1 - 2014/10
N2 - Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulted in enthusiasm for their use in prognostication and selection of appropriate therapies. However, despite considerable amounts of information available on numerous biomarkers, inconsistent research methodologies and lack of clinical correlations have made bench-to-bedside translations rare and left the literature with countless publications of varied quality. There is a need for a systematic and collaborative approach aimed at definitively studying the clinical benefits of novel biomarkers. In this review, on the basis of input from academia, industry, and governmental agencies, we propose a systematized approach based on adherence to specific quality measures for studies looking to augment current prediction model or use biomarkers to tailor therapeutics. We suggest that study quality, rather than results, should determine publication and propose a system for grading biomarker studies. We outline the need for collaboration between clinical investigators and statisticians to introduce more advanced statistical methodologies into the field of biomarkers that would allow for data from a large number of variables to be distilled into clinically actionable information. Lastly, we propose the creation of a heart failure biomarker consortium that would allow for a comprehensive list of biomarkers to be concomitantly analyzed in a pooled sample of randomized clinical trials and hypotheses to be generated for testing in biomarker-guided trials. Such a consortium could collaborate in sharing samples to identify biomarkers, undertake meta-analyses on completed trials, and spearhead clinical trials to test the clinical utility of new biomarkers.
AB - Heart failure is a syndrome with a pathophysiological basis that can be traced to dysfunction in several interconnected molecular pathways. Identification of biomarkers of heart failure that allow measurement of the disease on a molecular level has resulted in enthusiasm for their use in prognostication and selection of appropriate therapies. However, despite considerable amounts of information available on numerous biomarkers, inconsistent research methodologies and lack of clinical correlations have made bench-to-bedside translations rare and left the literature with countless publications of varied quality. There is a need for a systematic and collaborative approach aimed at definitively studying the clinical benefits of novel biomarkers. In this review, on the basis of input from academia, industry, and governmental agencies, we propose a systematized approach based on adherence to specific quality measures for studies looking to augment current prediction model or use biomarkers to tailor therapeutics. We suggest that study quality, rather than results, should determine publication and propose a system for grading biomarker studies. We outline the need for collaboration between clinical investigators and statisticians to introduce more advanced statistical methodologies into the field of biomarkers that would allow for data from a large number of variables to be distilled into clinically actionable information. Lastly, we propose the creation of a heart failure biomarker consortium that would allow for a comprehensive list of biomarkers to be concomitantly analyzed in a pooled sample of randomized clinical trials and hypotheses to be generated for testing in biomarker-guided trials. Such a consortium could collaborate in sharing samples to identify biomarkers, undertake meta-analyses on completed trials, and spearhead clinical trials to test the clinical utility of new biomarkers.
KW - Biomarkers/blood
KW - Cooperative Behavior
KW - Heart Failure/blood
KW - Humans
KW - Prognosis
KW - Research Design
U2 - 10.1016/j.jchf.2014.02.005
DO - 10.1016/j.jchf.2014.02.005
M3 - SCORING: Review article
C2 - 24929535
VL - 2
SP - 477
EP - 488
JO - JACC-HEART FAIL
JF - JACC-HEART FAIL
SN - 2213-1779
IS - 5
ER -