INHERENT DIFFICULTIES WITH ACTIVE CONTROL EQUIVALENCE STUDIES

被引:19
|
作者
SENN, S
机构
[1] Medical Department, Pharmaceutical Division, CIBA-GEIGY AG, Basle
关键词
D O I
10.1002/sim.4780122412
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
A simple model is used to investigate the relevance of 'competence' to active control equivalence studies (ACES). It is shown that to the extent that such trials are successful the results of such trials must raise doubts regarding their competence. ACES are thus more problematic than classical clinical trials and the problems with such studies cannot be solved simply by exchanging the usual roles of null and alternative hypotheses.
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页码:2367 / 2375
页数:9
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