• Hezhi Lu, Hua Jin, and Weixiong Zeng.
• School of Mathematical Sciences, South China Normal University, China.
• Stat Methods Med Res. 2018 Aug 1; 27 (8): 2437-2446.

AbstractHida and Tango established a statistical testing framework for the three-arm non-inferiority trial including a placebo with a pre-specified non-inferiority margin to overcome the shortcomings of traditional two-arm non-inferiority trials (such as having to choose the non-inferiority margin). In this paper, we propose a new method that improves their approach with respect to two aspects. We construct our testing statistics based on the best unbiased pooled estimators of the homogeneous variance; and we use the principle of intersection-union tests to determine the rejection rule. We theoretically prove that our test is better than that of Hida and Tango for large sample sizes. Furthermore, when that sample size was small or moderate, our simulation studies showed that our approach performed better than Hida and Tango's. Although both controlled the type I error rate, their test was more conservative and the statistical power of our test was higher.

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