Confirmatory clinical trials with an adaptive design

被引：21
|
作者：
Koch, Armin [1 ]
机构：
[1] Bundesinst Arzneimittel & Medizinprod, D-53175 Bonn, Germany
来源：
BIOMETRICAL JOURNAL | 2006年 / 48卷 / 04期
关键词：
adaptive designs; biostatistics; experimental design; phase III clinical trials;
D O I：
10.1002/bimj.200510239
中图分类号：
Q [生物科学];
学科分类号：
07 ; 0710 ; 09 ;
摘要：
Adaptive designs are one of the most promising developments in statistics with applications to clinical trials. Obviously, knowledge at the beginning of a clinical trial will always be limited. Thus it may seem logical that the knowledge from accumulating information should be used to optimize the design of the trial. This paper discusses conditions under which this may be possible in phase III clinical trials where the principal aim is confirmation of hypotheses that have been developed in earlier stages of drug development.
引用
收藏
页码：574 / 585
页数：12
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