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.

译文

:如果发生严重不良事件(SAE)的频率异常高,则需要统计方法来帮助决策过程,以继续进行试验。本文介绍了一个名为SAE的R包,该R包实现了一种新近开发的方法,该方法通过在每个观察到的SAE之后定义停止规则来实现。包装功能控制在观察每个SAE的试验期间(功能SAE)或在临床试验的规划阶段(功能设计)的过度毒性。此描述和软件包文档是互补的,以帮助用户应用该方法。该方法实施的主要困难是先验参数的选择。以正在进行的临床试验中的数据为例,以提高对包装的理解和使用。

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