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

Dan Sheng, Mimi Y. Kim

Research output: Contribution to journalArticlepeer-review

37 Scopus citations


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 languageEnglish (US)
Pages (from-to)1183-1199
Number of pages17
JournalStatistics in Medicine
Issue number7
StatePublished - Apr 15 2006


  • Equivalence trials
  • Inte-to-treat
  • Nom-compliance
  • Non-Inferiority trials

ASJC Scopus subject areas

  • Epidemiology
  • Statistics and Probability


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