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包括活性对照在内的多剂量实验中的测试策略。

Testing strategies in multi-dose experiments including active control.

作者信息

Bauer P, Röhmel J, Maurer W, Hothorn L

机构信息

Institut für Medizinische Statistik, Universität Wien, Austria.

出版信息

Stat Med. 1998 Sep 30;17(18):2133-46. doi: 10.1002/(sici)1097-0258(19980930)17:18<2133::aid-sim901>3.0.co;2-2.

Abstract

Inferential test strategies for multi-arm trials are adapted or proposed for the special situation when more than one dose of a test treatment, placebo and active control(s) are compared. This includes between doses, dose-placebo and dose-active-control comparisons. The procedures refer to situations when detailed comparisons make sense only if the sensitivity of the trial has been shown, for example, if a dose-response relationship or a difference between active control and placebo has been established. Split strategies, hierarchical (assuming an order restriction among doses) or linked procedures are introduced. In linked procedures, equivalence to the active control will be established only if the dose is also shown to be effective as compared to placebo. All the inferential procedures control the experimentwise error rate in the strong sense for the respective sets of null hypotheses considered.

摘要

针对多臂试验的推断性检验策略适用于或被提出用于比较一种试验治疗的多个剂量、安慰剂和活性对照的特殊情况。这包括剂量之间、剂量与安慰剂以及剂量与活性对照之间的比较。这些程序适用于仅当试验的敏感性已被证明时详细比较才有意义的情况,例如,如果已建立剂量反应关系或活性对照与安慰剂之间的差异。引入了拆分策略、分层策略(假设剂量之间存在顺序限制)或关联程序。在关联程序中,仅当该剂量与安慰剂相比也被证明有效时,才会确定其与活性对照等效。所有推断性程序都在强意义上控制了针对所考虑的各自零假设集的实验性错误率。

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