title: Statistical innovations in diagnostic device evaluation.
abstract: 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 at the Food and Drug Administration 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.
authors.affiliation: a Division of Biostatistics, Center for Devices and Radiological Health , U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Tinghui
authors.initials: T
authors.lastname: Yu
authors.affiliation: a Division of Biostatistics, Center for Devices and Radiological Health , U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Qin
authors.initials: Q
authors.lastname: Li
authors.affiliation: a Division of Biostatistics, Center for Devices and Radiological Health , U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Gerry
authors.initials: G
authors.lastname: Gray
authors.affiliation: a Division of Biostatistics, Center for Devices and Radiological Health , U.S. Food and Drug Administration , Silver Spring , Maryland , USA.
authors.forename: Lilly Q
authors.initials: LQ
authors.lastname: Yue
mesh_terms: D019937:Diagnostic Techniques and Procedures / Q000295:instrumentation*; D004864:Equipment and Supplies; D006801:Humans; D012107:Research Design; D013223:Statistics as Topic; D014481:United States; D014486:United States Food and Drug Administration
keywords: Biomarker; MRMC studies; ROC; bootstrap; companion diagnostics; missing data