Unité de Biostatistique, CRLC Val d'Aurelle - Paul Lamarque, 34298 Montpellier, France.
Comput Methods Programs Biomed. 2011 Nov;104(2):243-8. doi: 10.1016/j.cmpb.2011.05.005. Epub 2011 Jul 7.
In the case of an unexpected high frequency of serious adverse events (SAE), statistical methods are needed to help in the decision making process as to continuation of accrual to the trial. This paper describes an R package, named SAE that implements a method recently developed by defining stopping rules after each observed SAE. The package function control for excessive toxicity either during the trial at the observation of each SAE (function SAE) or during the planning phase of a clinical trial (function DESIGN). This description and the package documentation are complementary to help the users to apply the method. The main difficulty in the implementation of the method is the choice of a priori parameters. Data from an ongoing clinical trial are presented as an example to improve the understanding and the use of the package.
在严重不良事件（SAE）发生频率出乎意料高的情况下，需要使用统计方法来帮助决策是否继续进行试验入组。本文描述了一个名为 SAE 的 R 包，该包实现了一种最近开发的方法，通过在每次观察到 SAE 后定义停止规则来实现。该包的函数在试验期间（函数 SAE）或临床试验规划阶段（函数 DESIGN）控制过度毒性。本说明和包文档是互补的，以帮助用户应用该方法。该方法实施的主要难点是先验参数的选择。目前正在进行的临床试验的数据作为示例，以提高对包的理解和使用。
