An Approximate Unconditional Test of Non-Inferiority for Two Proportions Based on Odds Ratio Seo, Young-Yeol; Kim, Dong-Jae;
The hypotheses of difference, ratio and odds ratio between two proportions are used for the non-inferiority trial. The approximate unconditional test suggested by Kang and Chen (2000) based on difference and ratio have the potential problem against the failure rate. When the sample size is small, the type I errors of the asymptotic test using the normal approximation suggested by Chen et al. (2000) tends to exceed the nominal level. Therefore, we propose the approximate unconditional test based on odds ratio and compare the test with the asymptotic test. And we compare the three hypotheses used in the approximate unconditional tests of two proportions with respect to the type I errors and power.
Chen, J. J., Tseng, Y. and Kang, S. H. (2000). Tests for equivalence or noninferiority between two proportions, Drug Information Journal, 34, 569-578
Huque, M. F. and Dubey, S. (1990). Design and analysis for therapeutic equivalence clinical trials with binary clinical endpoints, In The 1990 Proceedings of the Biopharmaceutical Section of the American Statistical Association, 91-98
Kang, S. H. and Chen, J. J. (2000). An approximate unconditional test of non-inferiority between two proportions, Statistics in Medicine, 19, 2089-2100
Ng, T. H. (2008). Noninferiority hypotheses and choice of noninferiority margin, Statistics in Medicine, 27, 5392-5406
Tseng, Y., Wang, S. J., Hung, H. M. J. and Cui, L. (2003). Statistical issues on objective, design, and analysis of noninferiority active-controlled clinical trial, Journal of Biopharmaceutical Statistics, 13, 29-41