Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art: proceedings of the European Society of Cardiology—Cardiovascular Round Table
Cardiovascular Research, vol. 117, pp. 1248–1256
Abstract
Many biomarkers that could be used to assess ejection fraction, heart failure, or myocardial infarction fail to translate into clinical practice because they lack essential performance characteristics or fail to meet regulatory standards for approval. Despite their potential, new technologies have added to the complexities of successful translation into clinical practice. Biomarker discovery and implementation require a standardized approach that includes: identification of a clinical need; identification of a valid surrogate biomarker; stepwise assay refinement, demonstration of superiority over current standard-of-care; development and understanding of a clinical pathway; and demonstration of real-world performance. Successful biomarkers should improve efficacy or safety of treatment, while being practical at a realistic cost. Everyone involved in cardiovascular healthcare, including researchers, clinicians, and industry partners, are important stakeholders in facilitating the development and implementation of biomarkers. This article provides suggestions for a development pathway for new biomarkers, discusses regulatory issues and challenges, and suggestions for accelerating the pathway to improve patient outcomes. Real-life examples of successful biomarkers-high-sensitivity cardiac troponin, T2* cardiovascular magnetic resonance imaging, and echocardiography-are used to illustrate the value of a standardized development pathway in the translation of concepts into routine clinical practice.
Authors 19
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Perry Mark Elliott corresponding
Affiliation as printed
Cardiovascular Medicine, University College London, Gower Street, WC1E 6BT London, UK
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Affiliation as printed
Cardiology (Health Services Research), National Heart and Lung Institute, Imperial College London, Dovehouse Street, SW3 6LY London, UK
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Boehringer Ingelheim (Germany)
Affiliation as printed
Therapeutic Area, CardioMetabolism Respiratory Medicine, Boehringer-Ingelheim, Binger Straße 173, 55216 Ingelheim am Rhein, Germany
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Roche (Switzerland) · Roche Diagnostics International AG (Switzerland)
Affiliation as printed
Global Clinical Leader CVD, Roche Diagnostics International Ltd, RPD Medical & Scientific Affairs - Bldg 05 / 10th floor / Room 1.34 - Forrenstrasse 2 - CH 6343, Rotkreuz, Switzerland
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Affiliation as printed
Cardiovascular Medicine, Oxford University, Headley Way, Headington - OX3 9DU, Oxford, UK
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Leiden University · Leiden University Medical Center
Affiliation as printed
Non-Invasive Imaging and Echocardiography Lab, Leiden University Medical Centre, Albinusdreef 2 – 2333 ZA, Leiden, Netherlands
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University Hospitals Bristol NHS Foundation Trust · University of Bristol · NIHR Bristol Biomedical Research Centre
Affiliation as printed
Cardiology/Non-Invasive Imaging, Bristol Heart Institute, Bristol National Institute of Health Research (NIHR) Biomedical Research Centre, Clinical Research and Imaging Centre (CRIC) Bristol, University Hospitals Bristol NHS Trust and University of Bristol, Malborough St, Bristol, BS2 8HW, UK
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Uppsala University · Uppsala University Hospital
Affiliation as printed
Cardiology/Cardiac Imaging, Department of Medical Sciences, Uppsala University, Ingang 40, Plan 5 - S-751 85, Uppsala, Sweden
Clinical Physiology and Cardiology, Akademiska sjukhuset, Ingang 40, Plan 5 - S-751 85, Uppsala, Sweden
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Justus-Liebig-Universität Gießen
Affiliation as printed
Internal Medicine and Cardiology, Campus Kerckhoff, University of Giessen, Klinikstr. 33 - D-35392, Germany
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Amager Hospital · Copenhagen University Hospital
Affiliation as printed
Department of Cardiology, Copenhagen University Hospital, Amager-Hvidovre, Sankt Jakobs Gade 18, 4. Tv – 2100 Hvidovre, Denmark
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Affiliation as printed
Department of Internal Medicine III (Cardiology, Angiology, Pneumology), University of Heidelberg, Im Neuenheimer Feld 410 - D-69120, Heidelberg, Germany
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University of California San Diego
Affiliation as printed
Division of Cardiology, University of California—San Diego, 190 Del Mar Shores, #35; Solana Beach, CA 92075, USA
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Affiliation as printed
Clinical Lead for Heart Failure, King’s College Hospital, Denmark Hill - SE5 9RS London, UK
Clinical Lead for Heart Failure, King's College Hospital, Denmark Hill - SE5 9RS London, UK
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Federal Institute for Drugs and Medical Devices
Affiliation as printed
Department of Diabetes and Cardiovascular Diseases, BfArM, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn, Germany
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Affiliation as printed
G3 Pharmaceuticals, PO. Box 0024 Lexington, MA, 02420 USA
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Goethe University Frankfurt · German Centre for Cardiovascular Research · University Hospital Frankfurt
Affiliation as printed
Institute for Experimental and Translational Cardiovascular Imaging, DZHK (German Centre for Cardiovascular Research) Centre for Cardiovascular Imaging, Partner Site RheinMain, University Hospital, Goethe University, Haus 1, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany
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University of London · St George's Hospital · St George's, University of London · Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele
Affiliation as printed
Cardiology, St George’s Hospital, University of London, Blackshaw Road, Tooting, SW17 0QT London, UK
Department of Medical Sciences, IRCCS San Raffaele, Via Ardeatina 306-354, 00179 Roma, Italy
Cardiology, St George's Hospital, University of London, Blackshaw Road, Tooting, SW17 0QT London, UK
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Affiliation as printed
Department of Cardiology, University Hospital Basel, Petersgraben 4 – 4031, Basel, Switzerland
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Inserm · Centre Hospitalier Régional et Universitaire de Nancy · Université de Lorraine
Affiliation as printed
Université de Lorraine, Inserm CIC 1433, CHRU Nancy, FCRIN INI-CRCT, 4, rue du Morvan 54500 Vandoeuvre les Nancy, France
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