| Biomarkers and surrogates in clinical studies. | |
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MedLine Citation:
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PMID: 19160736 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Biomarkers are defined as anatomic, physiologic, biochemical, molecular, or genetic parameters associated with the presence, absence, or severity of a disease process. As such, biomarkers may be useful as prognostic and diagnostic tests. Establishing the utility of a given biomarker as a prognostic or diagnostic test requires the conduct of carefully designed cohort studies in which the biomarker and the outcome of interest are measured independently. The design and analysis of such studies is discussed. Surrogate outcomes in clinical trials consist of events or biomarkers intended to reflect important clinical outcomes. Surrogate outcomes may offer advantages in providing statistically robust estimates of treatment effects with smaller sample sizes. However, to be useful, surrogate outcomes have to be validated to ensure that the effect of therapy on them truly reflects the effect of therapy on the important clinical outcomes of interest. |
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Authors:
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Claudio Rigatto; Brendan J Barrett |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Methods in molecular biology (Clifton, N.J.) Volume: 473 ISSN: 1064-3745 ISO Abbreviation: Methods Mol. Biol. Publication Date: 2009 |
Date Detail:
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Created Date: 2009-01-23 Completed Date: 2009-02-10 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9214969 Medline TA: Methods Mol Biol Country: United States |
Other Details:
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Languages: eng Pagination: 137-54 Citation Subset: IM |
Affiliation:
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Department of Medicine, University of Manitoba, Winnipeg, Canada. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biological Markers* Clinical Trials as Topic / methods* Humans Outcome Assessment (Health Care) Predictive Value of Tests Research Design Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Biological Markers |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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