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Accuracy of a Biomarker Used for Classification or Prediction
Research methods for biomarker evaluation have lagged behind those for evaluating therapeutic treatments. Although a phased approach to the development of biomarkers and reporting guidelines is available, a comprehensive set of guidelines for study design has not been presented. Pepe et al. (p. 1432) describe a nested case–control study design, called the prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) design. This study design involves prospective collection of specimens from a study cohort, random selection of specimens from case patients and control subjects in the cohort, and the blinded assay of specimens. Details of the study design are described in relation
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