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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.
Keywords
biomarker implementation, clinical proteomics, Biomarker, clinical studies, expert panel, proteomics, CHRONIC KIDNEY-DISEASE, MASS-SPECTROMETRY, CLINICAL PROTEOMICS, CANCER BIOMARKERS, DRUG DEVELOPMENT, MICROVASCULAR OUTCOMES, DIABETES-MELLITUS, EUROPEAN BIOBANKS, CONTROLLED-TRIAL, MICROALBUMINURIA

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Citation

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Chicago
Mischak, Harald, John PA Ioannidis, Angel Argiles, Teresa K Attwood, Erik Bongcam-Rudloff, Mark Broenstrup, Aristidis Charonis, et al. 2012. “Implementation of Proteomic Biomarkers: Making It Work.” European Journal of Clinical Investigation 42 (9): 1027–1036.
APA
Mischak, H., Ioannidis, J. P., Argiles, A., Attwood, T. K., Bongcam-Rudloff, E., Broenstrup, M., Charonis, A., et al. (2012). Implementation of proteomic biomarkers: making it work. EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, 42(9), 1027–1036.
Vancouver
1.
Mischak H, Ioannidis JP, Argiles A, Attwood TK, Bongcam-Rudloff E, Broenstrup M, et al. Implementation of proteomic biomarkers: making it work. EUROPEAN JOURNAL OF CLINICAL INVESTIGATION. 2012;42(9):1027–36.
MLA
Mischak, Harald, John PA Ioannidis, Angel Argiles, et al. “Implementation of Proteomic Biomarkers: Making It Work.” EUROPEAN JOURNAL OF CLINICAL INVESTIGATION 42.9 (2012): 1027–1036. Print.
@article{3096759,
  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.},
  author       = {Mischak, Harald and Ioannidis, John PA and Argiles, Angel and Attwood, Teresa K and Bongcam-Rudloff, Erik and Broenstrup, Mark and Charonis, Aristidis and Chrousos, George P and Delles, Christian and Dominiczak, Anna and Dylag, Tomasz and Ehrich, Jochen and Egido, Jesus and Findeisen, Peter and Jankowski, Joachim and Johnson, Robert W and Julien, Bruce A and Lankisch, Tim and Leung, Hing Y and Maahs, David and Magni, Fulvio and Manns, Michael P and Manolis, Efthymios and Mayer, Gert and Navis, Gerjan and Novak, Jan and Ortiz, Alberto and Persson, Frederik and Peter, Karlheinz and Riese, Hans H and Rossing, Peter and Sattar, Naveed and Spasovski, Goce and Thongboonkerd, Visith and Vanholder, Raymond and Schanstra, Joost P and Vlahou, Antonia},
  issn         = {0014-2972},
  journal      = {EUROPEAN JOURNAL OF CLINICAL INVESTIGATION},
  language     = {eng},
  number       = {9},
  pages        = {1027--1036},
  title        = {Implementation of proteomic biomarkers: making it work},
  url          = {http://dx.doi.org/10.1111/j.1365-2362.2012.02674.x},
  volume       = {42},
  year         = {2012},
}

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