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

Perry Elliott; Martin R Cowie; Jennifer Franke; André Ziegler; Charalambos Antoniades; Jeroen Bax; Chiara Bucciarelli-Ducci; Frank A Flachskampf; Christian Hamm; Magnus T Jensen; Hugo Katus; Alan Maisel; Theresa McDonagh; Clemens Mittmann; Pieter Muntendam; Eike Nagel; Giuseppe Rosano; Raphael Twerenbold; Faiez Zannad

doi:10.1093/cvr/cvaa272

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

Standard

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, Perry; Cowie, Martin R; Franke, Jennifer; Ziegler, André; Antoniades, Charalambos; Bax, Jeroen; Bucciarelli-Ducci, Chiara; Flachskampf, Frank A; Hamm, Christian; Jensen, Magnus T; Katus, Hugo; Maisel, Alan; McDonagh, Theresa; Mittmann, Clemens; Muntendam, Pieter; Nagel, Eike; Rosano, Giuseppe; Twerenbold, Raphael; Zannad, Faiez.

in: CARDIOVASC RES, Jahrgang 117, Nr. 5, 23.04.2021, S. 1248-1256.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Elliott, P, Cowie, MR, Franke, J, Ziegler, A, Antoniades, C, Bax, J, Bucciarelli-Ducci, C, Flachskampf, FA, Hamm, C, Jensen, MT, Katus, H, Maisel, A, McDonagh, T, Mittmann, C, Muntendam, P, Nagel, E, Rosano, G, Twerenbold, R & Zannad, F 2021, 'Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art: proceedings of the European Society of Cardiology-Cardiovascular Round Table', CARDIOVASC RES, Jg. 117, Nr. 5, S. 1248-1256. https://doi.org/10.1093/cvr/cvaa272

APA

Elliott, P., Cowie, M. R., Franke, J., Ziegler, A., Antoniades, C., Bax, J., Bucciarelli-Ducci, C., Flachskampf, F. A., Hamm, C., Jensen, M. T., Katus, H., Maisel, A., McDonagh, T., Mittmann, C., Muntendam, P., Nagel, E., Rosano, G., Twerenbold, R., & Zannad, F. (2021). Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art: proceedings of the European Society of Cardiology-Cardiovascular Round Table. CARDIOVASC RES, 117(5), 1248-1256. https://doi.org/10.1093/cvr/cvaa272

Vancouver

Elliott P, Cowie MR, Franke J, Ziegler A, Antoniades C, Bax J et al. Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art: proceedings of the European Society of Cardiology-Cardiovascular Round Table. CARDIOVASC RES. 2021 Apr 23;117(5):1248-1256. https://doi.org/10.1093/cvr/cvaa272

Bibtex

@article{b2ea28421e9d4583a1d7a4e16578c073,

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",

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.",

author = "Perry Elliott and Cowie, {Martin R} and Jennifer Franke and Andr{\'e} Ziegler and Charalambos Antoniades and Jeroen Bax and Chiara Bucciarelli-Ducci and Flachskampf, {Frank A} and Christian Hamm and Jensen, {Magnus T} and Hugo Katus and Alan Maisel and Theresa McDonagh and Clemens Mittmann and Pieter Muntendam and Eike Nagel and Giuseppe Rosano and Raphael Twerenbold and Faiez Zannad",

year = "2021",

month = apr,

day = "23",

doi = "10.1093/cvr/cvaa272",

language = "English",

volume = "117",

pages = "1248--1256",

journal = "CARDIOVASC RES",

issn = "0008-6363",

publisher = "Oxford University Press",

number = "5",

}

RIS

TY - JOUR

T1 - Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art: proceedings of the European Society of Cardiology-Cardiovascular Round Table

AU - Elliott, Perry

AU - Cowie, Martin R

AU - Franke, Jennifer

AU - Ziegler, André

AU - Antoniades, Charalambos

AU - Bax, Jeroen

AU - Bucciarelli-Ducci, Chiara

AU - Flachskampf, Frank A

AU - Hamm, Christian

AU - Jensen, Magnus T

AU - Katus, Hugo

AU - Maisel, Alan

AU - McDonagh, Theresa

AU - Mittmann, Clemens

AU - Muntendam, Pieter

AU - Nagel, Eike

AU - Rosano, Giuseppe

AU - Twerenbold, Raphael

AU - Zannad, Faiez

PY - 2021/4/23

Y1 - 2021/4/23

N2 - 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.

AB - 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.

U2 - 10.1093/cvr/cvaa272

DO - 10.1093/cvr/cvaa272

M3 - SCORING: Journal article

C2 - 32960964

VL - 117

SP - 1248

EP - 1256

JO - CARDIOVASC RES

JF - CARDIOVASC RES

SN - 0008-6363

IS - 5

ER -