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May 2022

Test Statistics and sample size Formulae for Comparative Binomial Trials with Null Hypothesis of Non-Zero Risk Difference or Non-Unity Relative Risk

Author(s): Manning, G.

Journal/Book: Statistics in Medicine. 1990; 9: 1447-1454.

Abstract: When it is required to establish a materially significant difference between two treatments, or, alternatively,to show that two treatments are equivalent, standard test statistics and sample size formulae based an a nullhypothesis of no difference no longer apply. This paper reviews some of the test statistics and sample sizeformulae proposed for comparative binomial trials when the null hypothesis is of a specified non-zerodifference or non-unity relative risk. Methods based an restricted maximum likelihood estimation arerecommended and applied to studies of pertussis vaccine.

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