Scientific Publications by FDA Staff

J Biopharm Stat 2016;26(6):1067-77

Statistical innovations in diagnostic device evaluation.

Yu T, Li Q, Gray G, Yue L

Due to rapid technological development, innovations in diagnostic devices are proceeding at an extremely fast pace. Accordingly, the needs for adopting innovative statistical methods have emerged in the evaluation of diagnostic devices. Statisticians in the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) have provided leadership in implementing statistical innovations. The innovations discussed in this article include: the adoption of bootstrap and Jackknife methods, the implementation of appropriate multiple reader multiple case study design, the application of robustness analyses for missing data and the development of study designs and data analyses for companion diagnostics.