文章基本信息

标题：gsbDesign: An R Package for Evaluating the Operating Characteristics of a Group Sequential Bayesian Design
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作者：Florian Gerber ; Thomas Gsponer
期刊名称：Journal of Statistical Software
印刷版ISSN：1548-7660
电子版ISSN：1548-7660
出版年度：2016
卷号：69
期号：1
页码：1-23
语种：English
出版社：University of California, Los Angeles
摘要：The R package gsbDesign provides functions to evaluate the operating characteristics of Bayesian group sequential clinical trial designs. More specifically, we consider clinical trials with interim analyses, which compare a treatment with a control, and where the endpoint is normally distributed. Prior information can either be specified for the difference of treatment and control, or separately for the effects in the treatment and the control groups. At each interim analysis, the decision to stop or continue the trial is based on the posterior distribution of the difference between treatment and control. The decision at the final analysis is also based on this posterior distribution. Multiple success and/or futility criteria can be specified to reflect adequately medical decision-making. We describe methods to evaluate the operating characteristics of such designs for scenarios corresponding to different true treatment and control effects. The characteristics of main interest are the probabilities of success and futility at each interim analysis, and the expected sample size. We illustrate the use of gsbDesign with a detailed case study.
关键词：adaptive design;Bayesian inference;clinical trials;clinical trial monitoring;expected sample size;group sequential design;interim analyses;operating characteristics;stopping criteria