A Review of Methods and Applications of the ROC Curve in Clinical Trials

Title
A Review of Methods and Applications of the ROC Curve in Clinical Trials

Abstract
A receiver operating characteristic curve (ROC) is a statistical tool to assess the accuracy of a test. In this article, we propose to review the methods and applications of the ROC curve for various situations in clinical trials and drug development. The ROC curve is widely accepted as a method for selecting an optimal cutoff point and for comparing the accuracy of diagnostic tests. It is a plot of the true positive rate against the false positive rate for different cutoff points. The sensitivity and specificity of a test, however, depend on the level that has been chosen as a cutoff point for normal or abnormal. In bioavailability or bioequivalence (BA/ BE) studies, the area under the curve (AUC) is often used to measure the extent of absorption or total amount of drug absorbed into the body. AUC is usually calculated using a trapezoidal rule based on blood or plasma concentrations obtained at various sampling time points. In pharmacovigilance, the ROC curve is used in signal detection.