title: Statistical innovations in the medical device world sparked by the FDA.
abstract: The world of medical devices while highly diverse is extremely innovative, and this facilitates the adoption of innovative statistical techniques. 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 include: the incorporation of Bayesian methods in clinical trials, adaptive designs, the use and development of propensity score methodology in the design and analysis of non-randomized observational studies, the use of tipping-point analysis for missing data, techniques for diagnostic test evaluation, bridging studies for companion diagnostic tests, quantitative benefit-risk decisions, and patient preference studies.
authors.affiliation: a Center for Devices and Radiological Health , U.S. Food and Drug Administration , Silver Spring, Maryland , USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Campbell
authors.affiliation: a 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: D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D018795:Device Approval; D057069:Diagnostic Test Approval; D004864:Equipment and Supplies / Q000706:statistics & numerical data*; D006801:Humans; D064887:Observational Studies as Topic / Q000706:statistics & numerical data; D057216:Propensity Score; D012107:Research Design; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration
keywords: Adaptive designs; Bayesian statistics; clinical trials; diagnostic test evaluation; missing data; propensity score; quantitative benefit–risk