2010
DOI: 10.1097/coh.0b013e32833ed177
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What are biomarkers?

Abstract: Purpose This article provides working definitions and a conceptual framework to understand the roles of biomarkers in clinical research. Recent findings The definitions of the terms discussed in this article—medical signs, symptoms, biomarkers, surrogate endpoints, clinical endpoints, validation—are still under discussion, as are their relationships to each other, but broad consensus has developed in the past decade and a half about the necessity of distinguishing between, in particular, surrogate and clinic… Show more

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Cited by 1,670 publications
(1,055 citation statements)
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References 8 publications
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“…Biomarkers ( Figure 1C), a portmanteau of "biological markers" (123), has been defined as a substance or process that can be objectively and reproducibly measured as an indicator of either normal biological or pathological processes that influence or predict outcomes (124). In the acute care setting, these tend to be routinely collected laboratory tests (125), or organ specific tests for diagnostic and prognostic reasons (e.g.…”
Section: Biomarkersmentioning
confidence: 99%
“…Biomarkers ( Figure 1C), a portmanteau of "biological markers" (123), has been defined as a substance or process that can be objectively and reproducibly measured as an indicator of either normal biological or pathological processes that influence or predict outcomes (124). In the acute care setting, these tend to be routinely collected laboratory tests (125), or organ specific tests for diagnostic and prognostic reasons (e.g.…”
Section: Biomarkersmentioning
confidence: 99%
“…Biomarkers can assist clinicians in making a reliable diagnosis and can be used as a clinical endpoint surrogate in clinical trials. For both applications it is critical that the correlation between disease and biomarker is well characterized and validated [213].…”
Section: An Introduction To Biomarkersmentioning
confidence: 99%
“…Furthermore, it is of interest that the biomarker is easy accessible, thereby minimizing the burden for the patient. Finally, the sensitivity of the biomarker (or diagnostic assay to quantify the biomarker) will determine the extent to which early diagnosis is feasible [213].…”
Section: An Introduction To Biomarkersmentioning
confidence: 99%
“…In 1998, the National Institutes of Health Biomarkers Definitions Working Group defined a biomarker as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention" [1,2]. A joint venture on chemical safety, the International Programmed on Chemical Safety, led by the World Health Organization (WHO) and in coordination with the United Nations and the International Labor Organization, has defined a biomarker as "any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence of outcome or disease" [3].…”
Section: Introductionmentioning
confidence: 99%