DEVIANCE ESTIMATES OF SAMPLE-SIZE FOR EQUIVALENCE TESTS IN VACCINE TRIALS

This paper proposes a sample size procedure for both equivalence and conventional tests for the comparison of two binomial proportions, based on the signed square root of the deviance. When the comparison is based on the odds ratio, I describe an alternate 'close' conditional exact method that gives results that support those given by the deviance method. I summarize the advantages of the deviance-based method and also show that in general equivalence situations the sample size estimate depends upon the measure of comparison selected, odds ratio, risk ratio or risk difference.