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.
Highlights
Clinical proteomics is defined as proteome analysis intended to improve the medical practice, for example, in relation to diagnosis, prevention, prognosis or therapy
Multiple proteomic biomarkers have been described for a variety of diseases, and several biomarkers have shown added value over current disease-management approaches, based on validation studies
Implementation of biomarkers is a complex process that would significantly benefit from the establishment of a general road map
Summary
Clinical proteomics is defined as proteome analysis intended to improve the medical practice, for example, in relation to diagnosis, prevention, prognosis or therapy. Its success should be judged from the conferred clinical impact after implementation of its findings in everyday practice. The last decade has been marked by significant technological advancements in proteomics, especially with regard to mass spectrometry and bioinformatic solutions for data analysis. Multiple proteomic biomarkers have been described for a variety of diseases, and several biomarkers have shown added value over current disease-management approaches, based on validation studies (e.g. in chronic kidney disease [1,2,3], reviewed in [4,5]). Implementation of the results in medical practice appears to be scarce [6]. The impact of clinical proteomics (and biomarkers in general) on clinical decision-making, patient management and welfare appears insufficient
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