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The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications

BACKGROUND: Translating prognostic and diagnostic biomarker candidates into clinical applications takes time, is very costly, and many candidates fail. It is therefore crucial to be able to select those biomarker candidates that have the highest chance of successfully being adopted in the clinic. Th...

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Autores principales: de Graaf, Gimon, Postmus, Douwe, Westerink, Jan, Buskens, Erik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6006586/
https://www.ncbi.nlm.nih.gov/pubmed/29946228
http://dx.doi.org/10.1186/s12962-018-0105-z
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author de Graaf, Gimon
Postmus, Douwe
Westerink, Jan
Buskens, Erik
author_facet de Graaf, Gimon
Postmus, Douwe
Westerink, Jan
Buskens, Erik
author_sort de Graaf, Gimon
collection PubMed
description BACKGROUND: Translating prognostic and diagnostic biomarker candidates into clinical applications takes time, is very costly, and many candidates fail. It is therefore crucial to be able to select those biomarker candidates that have the highest chance of successfully being adopted in the clinic. This requires an early estimate of the potential clinical impact and commercial value. In this paper, we aim to demonstratively evaluate a set of novel biomarkers in terms of clinical impact and commercial value, using occurrence of cardiovascular disease (CVD) in type-2 diabetes (DM2) patients as a case study. METHODS: We defined a clinical application for the novel biomarkers, and subsequently used data from a large cohort study in The Netherlands in a modeling exercise to assess the potential clinical impact and headroom for the biomarkers. RESULTS: The most likely application of the biomarkers would be to identify DM2 patients with a low CVD risk and subsequently withhold statin treatment. As a result, one additional CVD event in every 75 patients may be expected. The expected downstream savings resulted in a headroom for a point-of-care device ranging from €119.09 at a willingness to accept of €0 for one additional CVD event, to €0 at a willingness to accept of €15,614 or more. CONCLUSION: It is feasible to evaluate novel biomarkers on outcomes directly relevant to technological development and clinical adoption. Importantly, this may be attained at the same point in time and using the same data as used for the evaluation of association with disease and predictive power.
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spelling pubmed-60065862018-06-26 The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications de Graaf, Gimon Postmus, Douwe Westerink, Jan Buskens, Erik Cost Eff Resour Alloc Methodology BACKGROUND: Translating prognostic and diagnostic biomarker candidates into clinical applications takes time, is very costly, and many candidates fail. It is therefore crucial to be able to select those biomarker candidates that have the highest chance of successfully being adopted in the clinic. This requires an early estimate of the potential clinical impact and commercial value. In this paper, we aim to demonstratively evaluate a set of novel biomarkers in terms of clinical impact and commercial value, using occurrence of cardiovascular disease (CVD) in type-2 diabetes (DM2) patients as a case study. METHODS: We defined a clinical application for the novel biomarkers, and subsequently used data from a large cohort study in The Netherlands in a modeling exercise to assess the potential clinical impact and headroom for the biomarkers. RESULTS: The most likely application of the biomarkers would be to identify DM2 patients with a low CVD risk and subsequently withhold statin treatment. As a result, one additional CVD event in every 75 patients may be expected. The expected downstream savings resulted in a headroom for a point-of-care device ranging from €119.09 at a willingness to accept of €0 for one additional CVD event, to €0 at a willingness to accept of €15,614 or more. CONCLUSION: It is feasible to evaluate novel biomarkers on outcomes directly relevant to technological development and clinical adoption. Importantly, this may be attained at the same point in time and using the same data as used for the evaluation of association with disease and predictive power. BioMed Central 2018-06-18 /pmc/articles/PMC6006586/ /pubmed/29946228 http://dx.doi.org/10.1186/s12962-018-0105-z Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Methodology
de Graaf, Gimon
Postmus, Douwe
Westerink, Jan
Buskens, Erik
The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
title The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
title_full The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
title_fullStr The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
title_full_unstemmed The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
title_short The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
title_sort early economic evaluation of novel biomarkers to accelerate their translation into clinical applications
topic Methodology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6006586/
https://www.ncbi.nlm.nih.gov/pubmed/29946228
http://dx.doi.org/10.1186/s12962-018-0105-z
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