Testing strategies in multi-dose experiments including active control

被引:0
|
作者
Bauer, P
Rohmel, J
Maurer, W
Hothorn, L
机构
[1] Univ Vienna, Inst Med Stat, A-1090 Vienna, Austria
[2] Bundesinst Arzneimittel & Med Prod, D-13353 Berlin, Germany
[3] Novartis Pharma AG, MIPS Biostat, CH-4002 Basel, Switzerland
[4] Univ Hannover, FB Gartenbau, LG Bioinformat, D-30419 Hannover, Germany
关键词
D O I
10.1002/(SICI)1097-0258(19980930)17:18<2133::AID-SIM901>3.0.CO;2-2
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
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. (C) 1998 John Wiley & Sons, Ltd.
引用
收藏
页码:2133 / 2146
页数:14
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