Statistical Methods for Test and Biomarker Evaluation Studies: A Clinical Chemistry Series

Abstract

Studies related to the development and evaluation of biomarkers constitute a major portion of the published work in Clinical Chemistry . In 2011, for example, approximately 70% of original articles considered these topics. Owing to the importance of biomarker evaluation, knowledge of statistical approaches for assessing biomarker data has become increasingly necessary, and the surprisingly high citation rates for many articles on such statistical approaches [e.g., (1–3)] would appear to support this view. 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. The latter can range from simple measures of diagnostic …