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Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio.

Research output: Contribution to journalJournal article


<mark>Journal publication date</mark>10/02/2008
<mark>Journal</mark>Statistics in Medicine
Issue number3
Number of pages18
Pages (from-to)353-370
<mark>Original language</mark>English


This paper considers methods for testing for superiority or non-inferiority in active-control trials with binary data, when the relative treatment effect is expressed as an odds ratio. Three asymptotic tests for the log-odds ratio based on the unconditional binary likelihood are presented, namely the likelihood ratio, Wald and score tests. All three tests can be implemented straightforwardly in standard statistical software packages, as can the corresponding confidence intervals. Simulations indicate that the three alternatives are similar in terms of the Type I error, with values close to the nominal level. However, when the non-inferiority margin becomes large, the score test slightly exceeds the nominal level. In general, the highest power is obtained from the score test, although all three tests are similar and the observed differences in power are not of practical importance.