Journal article

Development, validation and implementation of biomarker testing in cardiovascular medicine state-of-the-art: Proceedings of the European Society of Cardiology - Cardiovascular Round Table.

  • Elliott P Professor of Cardiovascular Medicine, University College London, London, UK.
  • Cowie MR Chair of Cardiology (Health Services Research), National Heart and Lung Institute, Imperial College London, London, UK.
  • Franke J Global Medical Director, Therapeutic Area CardioMetabolism Respiratory Medicine Boehringer-Ingelheim, Ingelheim, Germany.
  • Ziegler A Global Clinical Leader CVD, Roche Diagnostics International Ltd. Rotkreuz, Switzerland.
  • Antoniades C Professor of Cardiovascular Medicine, Oxford University, Oxford, UK.
  • Bax J Director, Non-invasive Imaging and Echocardiography Lab, Leiden University Medical Centre, Leiden, Netherlands.
  • Bucciarelli-Ducci C Consultant Senior Lecturer, 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. Bristol, United Kingdom.
  • Flachskampf FA Professor of Cardiology/Cardiac Imaging, Dept.Medical Sciences, Uppsala University, and Clinical Physiology and Cardiology, Akademiska sjukhuset, Uppsala, Sweden.
  • Hamm C Professor of Internal Medicine and Cardiology, Campus Kerckhoff, University of Giessen, Germany.
  • Jensen MT Head of Department of Cardiology, Copenhagen University Hospital, Amager-Hvidovre, Hvidovre, Denmark.
  • Katus H Director, Department of Internal Medicine III (Cardiology, Angiology, Pneumology), University of Heidelberg, Heidelberg, Germany.
  • Maisel A Professor Emeritus, Division of Cardiology, University of California-San Diego, San Diego, CA, USA.
  • McDonagh T Clinical Lead for Heart Failure, King's College Hospital, London, UK.
  • Mittmann C Vize head, Department of Diabetes and Cardiovascular Diseases, BfArM, Germany, Bonn, Germany.
  • Muntendam P President & CEO, G3 Pharmaceuticals, Lexington, MA, USA.
  • Nagel E Director, Institute for Experimental and Translational Cardiovascular Imaging, DZHK (German Centre for Cardiovascular Research) Centre for Cardiovascular Imaging, Partner Site RheinMain, University Hospital, Goethe University, Frankfurt am Main, Germany.
  • Rosano G Director Department of Medical Sciences IRCCS San Raffaele Roma, Italy and Professor of Cardiology, St George's Hospital University of London, London, UK.
  • Twerenbold R Interventional Cardiologist, Department of Cardiology, University Hospital Basel, Basel, Switzerland.
  • Zannad F Université de Lorraine, Inserm CIC 1433, CHRU Nancy, FCRIN INI-CRCT, Nancy France.
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  • 2020-09-22
Published in:
  • Cardiovascular research. - 2020
English 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 requires a standardised 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 paper 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 (hs-cTn), T2* cardiovascular magnetic resonance (CMR) imaging, and echocardiography-are used to illustrate the value of a standardised development pathway in the translation of concepts into routine clinical practice.
Language
  • English
Open access status
hybrid
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Persistent URL
https://folia.unifr.ch/global/documents/206913
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