Comparisons of Test Statistics for Noninferiority Test for the Difference between Two Independent Binominal Proportions

Abstract: Problem statement: Noninferiority tests are frequently used in clinical trials to demonstrate that the response for study drugs is not much worse than the response for reference drugs. Several test statistics exist. However, a detailed comparison of those test statistics is not researched. Moreover, a little complex calculation might be necessary in some of those test statistics. Approach: In this study, we investigated the performance of the existing test statistics and propose new test statistics. Further, we compare them with existing test methods by means of simulation and devise a suitable technique of using of these test statistics. Results: We found that for the proposed test statistics, the actual type I error was close to the nominal level. Further, when the sample size is moderate it is found that, the new test statistics have a little higher power than other test statistics. Conclusion: One of the biggest advantages of our method is that it does not require complicated calculations. Key words: On-sided testing, non-inferiority trials, binominal proportion