The effects of non-compliance on intent-to-treat analysis of equivalence trials

被引:28
作者
Sheng, D
Kim, MY
机构
[1] NYU, Dept Environm Med, Sch Med, Div Biostat, New York, NY 10016 USA
[2] Albert Einstein Coll Med, Div Biostat, Dept Epidemiol & Populat Hlth, Bronx, NY 10467 USA
关键词
non-compliance; equivalence trials; non-inferiority trials; intent-to-treat;
D O I
10.1002/sim.2230
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
The standard approach for analysing a randomized clinical trial is based on intent-to-treat (ITT) where subjects are analysed according to their assigned treatment group regardless of actual adherence to the treatment protocol. For therapeutic equivalence trials, it is a common concern that an ITT analysis increases the chance of erroneously concluding equivalence. In this paper, we formally investigate the impact of non-compliance on an ITT analysis of equivalence trials with a binary outcome. We assume 'all-or-none' compliance and independence between compliance and the outcome. Our results indicate that non-compliance does not always make it easier to demonstrate equivalence. The direction and magnitude of changes in the type I error rate and power of the study depend on the patterns of noncompliance, event probabilities, the margin of equivalence and other factors. Copyright (c) 2005 John Wiley & Sons, Ltd.
引用
收藏
页码:1183 / 1199
页数:17
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