Harald MischakJohn P.A. IoannidisAngel ArgilesTeresa K. AttwoodErik Bongcam-RudloffMark BroenstrupAristidis CharonisGeorge P. ChrousosChristian DellesAnna DominiczakTomasz DylagJochen EhrichJesus EgidoPeter FindeisenJoachim JankowskiRobert W. JohnsonBruce A. JulienTim LankischHing Y. LeungDavid MaahsFulvio MagniMichael P. MannsEfthymios ManolisGert MayerGerjan NavisJan NovakAlberto OrtizFrederik PerssonKarlheinz PeterHans H. RiesePeter RossingNaveed SattarGoce SpasovskiVisith ThongboonkerdRaymond VanholderJoost P. SchanstraAntonia VlahouUniversity of GlasgowMosaiques DiagnosticsUniversity of Ioannina, School of MedicineStanford University School of MedicineStanford UniversityRD NéphrologieUniversity of ManchesterUppsala UniversitetSveriges lantbruksuniversitetSanofi-Aventis Deutschland GmbHAcademy of AthensUniversity of Athens Medical SchoolEuropean CommissionMedizinische Hochschule Hannover (MHH)Universidad Autonoma de MadridUniversitatsklinikum MannheimCharité – Universitätsmedizin BerlinAbbott LaboratoriesUniversity of Alabama at BirminghamBeatson Institute for Cancer ResearchUniversity of Colorado Health Sciences CenterUniversita degli Studi di Milano - BicoccaEuropean Medicines AgencyMedizinische Universitat InnsbruckUniversity of Groningen, University Medical Center GroningenSteno Diabetes CenterBaker Heart and Diabetes InstituteInstituto de Salud Carlos IIISS Cyril and Methodius University Faculty of MedicineMahidol UniversityUniversity Hospital of GhentUniversite Paul Sabatier Toulouse III2018-06-112018-06-112012-09-01European Journal of Clinical Investigation. Vol.42, No.9 (2012), 1027-103613652362001429722-s2.0-84865194855https://repository.li.mahidol.ac.th/handle/20.500.14594/13629While 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.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyArticleSCOPUS10.1111/j.1365-2362.2012.02674.x