title: Bayesian statistics in medical devices: innovation sparked by the FDA.
abstract: Bayesian statistical methodology has been used for more than 10 years in medical device premarket submissions to the U.S. Food and Drug Administration (FDA). A complete list of the publicly available information associated with these FDA applications is presented. In addition to the increasing number of Bayesian methodological papers in the statistical journals, a number of successful Bayesian clinical trials in the biomedical journals have been recently reported. Some challenges that require more methodological development are discussed. The promise of using Bayesian methods for incorporation of prior information as well as for conducting adaptive trials is great.
authors.affiliation: Food and Drug Administration, Division of Biostatistics, Silver Spring, Marlyand 20993, USA. Greg.campbell@fda.hhs.gov
authors.forename: Gregory
authors.initials: G
authors.lastname: Campbell
mesh_terms: D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data / Q000639:trends; D003201:Computers; D003661:Decision Support Techniques; D018795:Device Approval; D004864:Equipment and Supplies / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data / Q000639:trends; D012107:Research Design / Q000706:statistics & numerical data* / Q000639:trends; D012984:Software / Q000706:statistics & numerical data / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration