The use of Bayesian adaptive designs for randomised controlled trials has been hindered by the lack of software readily available to statisticians. We have developed a new software package (Bayesian Adaptive Trials Simulator Software - BATSS for the statistical software R, which provides a flexible structure for the fast simulation of Bayesian adaptive designs for clinical trials. We illustrate how the BATSS package can be used to define and evaluate the operating characteristics of Bayesian adaptive designs for various different types of primary outcomes (e.g., those that follow a normal, binary, Poisson or negative binomial distribution) and can incorporate the most common types of adaptations: stopping treatments (or the entire trial) for efficacy or futility, and Bayesian response adaptive randomisation - based on user-defined adaptation rules. Other important features of this highly modular package include: the use of (Integrated Nested) Laplace approximations to compute posterior distributions, parallel processing on a computer or a cluster, customisability, adjustment for covariates and a wide range of available conditional distributions for the response.

翻译：贝叶斯自适应设计在随机对照试验中的应用一直受到统计学家可用软件匮乏的阻碍。我们开发了一个新的软件包（Bayesian Adaptive Trials Simulator Software - BATSS），适用于统计软件R，它为临床试验的贝叶斯自适应设计提供了灵活的快速仿真结构。我们阐述了如何利用BATSS软件包来定义和评估针对不同类型主要结局（例如，服从正态分布、二项分布、泊松分布或负二项分布的结局）的贝叶斯自适应设计的操作特性，并能够整合最常见的适应性调整类型：基于用户定义的调整规则，因有效性或无效性而停止治疗（或整个试验），以及基于贝叶斯响应自适应随机化。这个高度模块化软件包的其他重要特性包括：使用（集成嵌套）拉普拉斯近似来计算后验分布、在单台计算机或集群上进行并行处理、可定制性、协变量调整以及广泛的响应条件分布选择。