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To comprehend the rapidly growing literature regarding the utility of new biomarkers, readers must develop familiarity with a growing list of statistical concepts, not only of how biomarker studies should be conducted and evaluated but also of the statistical methods used to evaluate the data from such studies. To facilitate a better understanding of these methods, the editors invited a group of respected epidemiologists and biostatisticians to prepare a series of review articles that would carefully examine the statistical methods currently used for biomarker evaluation and that would provide a foundation for interpreting data from studies in the current literature that evaluate diagnostic tests.