Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design

Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been deli...

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Bibliographic Details
Published in:JNCI : Journal of the National Cancer Institute Vol. 100; no. 20; p. 1432
Main Authors: Pepe, Margaret S, Feng, Ziding, Janes, Holly, Bossuyt, Patrick M, Potter, John D
Format: Journal Article
Language:English
Published: United States 15.10.2008
Subjects:
Biomarkers, Tumor - analysis
Case-Control Studies
Humans
Neoplasms - classification
Neoplasms - diagnosis
Predictive Value of Tests
Research Design
ISSN:1460-2105, 1460-2105
Online Access:Get more information
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Summary:Research methods for biomarker evaluation lag behind those for evaluating therapeutic treatments. Although a phased approach to development of biomarkers exists and guidelines are available for reporting study results, a coherent and comprehensive set of guidelines for study design has not been delineated. We describe a nested case-control study design that involves prospective collection of specimens before outcome ascertainment from a study cohort that is relevant to the clinical application. The biomarker is assayed in a blinded fashion on specimens from randomly selected case patients and control subjects in the study cohort. We separately describe aspects of the design that relate to the clinical context, biomarker performance criteria, the biomarker test, and study size. The design can be applied to studies of biomarkers intended for use in disease diagnosis, screening, or prognosis. Common biases that pervade the biomarker research literature would be eliminated if these rigorous standards were followed.
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ISSN:1460-2105
1460-2105
DOI:10.1093/jnci/djn326