Biomarker discovery study design consistent with the receiver-operator characteristic.

Abstract

The field of early biomarker discovery is characterized by a lack of consensus on the choice of statistical methodology, which may impede later progress towards clinically useful biomarkers. The Receiver-Operator Characteristic (ROC) is a de facto standard for determining the performance of In Vitro Diagnostic (IVD) devices. In this study, we aimed to systematically identify and mitigate prevalent pitfalls in biomarker discovery efforts and propose a best-practice guideline based on a ROC analys