Abstract
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 non-compliance, event probabilities, the margin of equivalence and other factors.
Original language | English (US) |
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Pages (from-to) | 1183-1199 |
Number of pages | 17 |
Journal | Statistics in Medicine |
Volume | 25 |
Issue number | 7 |
DOIs | |
State | Published - Apr 15 2006 |
Keywords
- Equivalence trials
- Inte-to-treat
- Nom-compliance
- Non-Inferiority trials
ASJC Scopus subject areas
- Epidemiology
- Statistics and Probability