UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

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; Cowie, MR; Franke, J; Ziegler, A; Antoniades, C; Bax, J; Bucciarelli-Ducci, C; ... Zannad, F; + view all (2020) 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 10.1093/cvr/cvaa272. (In press).

[img] Text
cvaa272.pdf - Accepted version
Access restricted to UCL open access staff until 23 September 2021.

Download (696kB)

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 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.

Type: Article
Title: Development, validation and implementation of biomarker testing in cardiovascular medicine state-of-the-art: Proceedings of the European Society of Cardiology - Cardiovascular Round Table
Location: England
DOI: 10.1093/cvr/cvaa272
Publisher version: http://dx.doi.org/10.1093/cvr/cvaa272
Language: English
Additional information: This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions.
Keywords: biomarker, ejection fraction, heart failure, magnetic resonance, myocardial infarction, pathway, troponin
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Cardiovascular Science
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Cardiovascular Science > Clinical Science
URI: https://discovery.ucl.ac.uk/id/eprint/10111449
Downloads since deposit
1Download
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item