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Implementation of proteomic biomarkers: making it work

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  • Harald Mischak
  • John P A Ioannidis
  • Angel Argilés
  • Teresa K Attwood
  • Erik Bongcam-Rudloff
  • Mark Broenstrup
  • Aristidis Charonis
  • George P Chrousos
  • Christian Delles
  • Anna Dominiczak
  • Tomasz Dylag
  • Jochen H H Ehrich
  • Jesus Egido
  • Peter Findeisen
  • Joachim Jankowski
  • Robert W Johnson
  • Bruce A Julien
  • Tim Lankisch
  • Hing Y Leung
  • David M 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
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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.

OriginalsprogEngelsk
TidsskriftEuropean Journal of Clinical Investigation
Vol/bind42
Udgave nummer9
Sider (fra-til)1027-36
Antal sider10
ISSN0014-2972
DOI
StatusUdgivet - sep. 2012
Eksternt udgivetJa

ID: 51600063