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Abstract:
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Non-inferiority trials are becoming very popular for comparative effectiveness research. These trials are required to show that the effect of an experimental treatment is not worse than that of a reference treatment by more than a specified margin. Hence non-inferiority trials are of great importance when superiority can not be claimed. In this paper we consider a three-arm non-inferiority trial consists of a placebo, a reference treatment, and an experimental treatment. However, unlike the traditional choices, we assume that the distributions of the end points corresponding to these treatments are unknown and suggest test procedures for a three-arm non-inferiority trial based on the balanced simultaneous confidence sets. The theoretical properties of our method are also investigated. The usefulness of the suggested method is illustrated through simulation results.
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