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Title: Implementation of proteomic biomarkers: Making it work
Authors: Harald Mischak
John P.A. Ioannidis
Angel Argiles
Teresa K. Attwood
Erik Bongcam-Rudloff
Mark Broenstrup
Aristidis Charonis
George P. Chrousos
Christian Delles
Anna Dominiczak
Tomasz Dylag
Jochen Ehrich
Jesus Egido
Peter Findeisen
Joachim Jankowski
Robert W. Johnson
Bruce A. Julien
Tim Lankisch
Hing Y. Leung
David Maahs
Fulvio Magni
Michael P. Manns
Efthymios Manolis
Gert Mayer
Gerjan Navis
Jan Novak
Alberto Ortiz
Frederik Persson
Karlheinz Peter
Hans H. Riese
Peter Rossing
Naveed Sattar
Goce Spasovski
Visith Thongboonkerd
Raymond Vanholder
Joost P. Schanstra
Antonia Vlahou
University of Glasgow
Mosaiques Diagnostics
University of Ioannina, School of Medicine
Stanford University School of Medicine
Stanford University
RD Néphrologie
University of Manchester
Uppsala Universitet
Sveriges lantbruksuniversitet
Sanofi-Aventis Deutschland GmbH
Academy of Athens
University of Athens Medical School
European Commission
Medizinische Hochschule Hannover (MHH)
Universidad Autonoma de Madrid
Universitatsklinikum Mannheim
Charité – Universitätsmedizin Berlin
Abbott Laboratories
University of Alabama at Birmingham
Beatson Institute for Cancer Research
University of Colorado Health Sciences Center
Universita degli Studi di Milano - Bicocca
European Medicines Agency
Medizinische Universitat Innsbruck
University of Groningen, University Medical Center Groningen
Steno Diabetes Center
Baker Heart and Diabetes Institute
Instituto de Salud Carlos III
SS Cyril and Methodius University Faculty of Medicine
Mahidol University
University Hospital of Ghent
Universite Paul Sabatier Toulouse III
Keywords: Biochemistry, Genetics and Molecular Biology
Issue Date: 1-Sep-2012
Citation: European Journal of Clinical Investigation. Vol.42, No.9 (2012), 1027-1036
Abstract: While large numbers of proteomic biomarkers have been described, they are generally not implemented in medical practice. We have investigated the reasons for this shortcoming, focusing on hurdles downstream of biomarker verification, and describe major obstacles and possible solutions to ease valid biomarker implementation. Some of the problems lie in suboptimal biomarker discovery and validation, especially lack of validated platforms with well-described performance characteristics to support biomarker qualification. These issues have been acknowledged and are being addressed, raising the hope that valid biomarkers may start accumulating in the foreseeable future. However, successful biomarker discovery and qualification alone does not suffice for successful implementation. Additional challenges include, among others, limited access to appropriate specimens and insufficient funding, the need to validate new biomarker utility in interventional trials, and large communication gaps between the parties involved in implementation. To address this problem, we propose an implementation roadmap. The implementation effort needs to involve a wide variety of stakeholders (clinicians, statisticians, health economists, and representatives of patient groups, health insurance, pharmaceutical companies, biobanks, and regulatory agencies). Knowledgeable panels with adequate representation of all these stakeholders may facilitate biomarker evaluation and guide implementation for the specific context of use. This approach may avoid unwarranted delays or failure to implement potentially useful biomarkers, and may expedite meaningful contributions of the biomarker community to healthcare. © 2012 The Authors. European Journal of Clinical Investigation © 2012 Stichting European Society for Clinical Investigation Journal Foundation.
ISSN: 13652362
Appears in Collections:Scopus 2011-2015

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