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The effects of non‐compliance on intent‐to‐treat analysis of equivalence trials
Author(s) -
Sheng Dan,
Kim Mimi Y.
Publication year - 2006
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.2230
Subject(s) - equivalence (formal languages) , compliance (psychology) , outcome (game theory) , treatment effect , intention to treat analysis , statistics , medicine , clinical trial , econometrics , psychology , mathematics , social psychology , mathematical economics , discrete mathematics , traditional medicine
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. Copyright © 2005 John Wiley & Sons, Ltd.