| |  Online-Ressource |
|---|
| Verfasst von: | Elliott, Perry [VerfasserIn]  |
|---|
| | Cowie, Martin R [VerfasserIn] |
|---|
| | Franke, Jennifer [VerfasserIn] |
|---|
| | Ziegler, André [VerfasserIn] |
|---|
| | Antoniades, Charalambos [VerfasserIn] |
|---|
| | Bax, Jeroen [VerfasserIn] |
|---|
| | Bucciarelli-Ducci, Chiara [VerfasserIn] |
|---|
| | Flachskampf, Frank A [VerfasserIn] |
|---|
| | Hamm, Christian [VerfasserIn] |
|---|
| | Jensen, Magnus T [VerfasserIn] |
|---|
| | Katus, Hugo [VerfasserIn] |
|---|
| | Maisel, Alan [VerfasserIn] |
|---|
| | McDonagh, Theresa [VerfasserIn] |
|---|
| | Mittmann, Clemens [VerfasserIn] |
|---|
| | Muntendam, Pieter [VerfasserIn] |
|---|
| | Nagel, Eike [VerfasserIn] |
|---|
| | Rosano, Giuseppe [VerfasserIn] |
|---|
| | Twerenbold, Raphael [VerfasserIn] |
|---|
| | Zannad, Faiez [VerfasserIn] |
|---|
| Titel: | Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art |
|---|
| Titelzusatz: | proceedings of the European Society of Cardiology : Cardiovascular Round Table |
|---|
| Verf.angabe: | 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, and Faiez Zannad |
|---|
| Jahr: | 2021 |
|---|
| Umfang: | 9 S. |
|---|
| Teil: | volume:117 |
|---|
| | year:2021 |
|---|
| | number:5 |
|---|
| | pages:1248-1256 |
|---|
| | extent:9 |
|---|
| Fussnoten: | Online published-ahead-of-print 22 September 2020 ; Gesehen am 23.08.2021 |
|---|
| Titel Quelle: | Enthalten in: Cardiovascular research |
|---|
| Ort Quelle: | Oxford : Oxford University Press, 1967 |
|---|
| Jahr Quelle: | 2021 |
|---|
| Band/Heft Quelle: | 117(2021), 5, Seite 1248-1256 |
|---|
| ISSN Quelle: | 1755-3245 |
|---|
| 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. |
|---|
| DOI: | doi:10.1093/cvr/cvaa272 |
|---|
| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext ; Verlag ; Resolving-System: https://academic.oup.com/cardiovascres/article/117/5/1248/5909990 |
|---|
| | Volltext: https://doi.org/10.1093/cvr/cvaa272 |
|---|
| | DOI: https://doi.org/10.1093/cvr/cvaa272 |
|---|
| Datenträger: | Online-Ressource |
|---|
| Sprache: | eng |
|---|
| K10plus-PPN: | 1767682204 |
|---|
| Verknüpfungen: | → Zeitschrift |
|---|
Development, validation, and implementation of biomarker testing in cardiovascular medicine state-of-the-art / Elliott, Perry [VerfasserIn]; 2021 (Online-Ressource)
