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- W4383175803 abstract "Simultaneous tests of superiority and non-inferiority hypotheses on multiple endpoints are often performed in clinical trials to demonstrate that a new treatment is superior over a control on at least one endpoint and non-inferior on the remaining endpoints. Existing methods tackle this problem by testing the superiority and non-inferiority hypotheses separately and control the Type I error rate each at $alpha$ level. In this paper we propose a unified approach to testing the superiority and non-inferiority hypotheses simultaneously. The proposed approach is based on the UI-IU test and the least favorable configurations of the combined superiority and non-inferiority hypotheses, which leads to the solution of an adjusted significance level $alpha'$ for marginal tests that controls the overall Type I error rate at pre-defined $alpha$. Simulations show that the proposed approach maintains a higher power than existing methods in the settings under investigation. Since the adjusted significance level $alpha'$ is obtained by controlling the Type I error rate at $alpha$, one can easily construct the exact $(1 - alpha)%$ simultaneous confidence intervals for treatment effects on all endpoints. The proposed approach is illustrated with two real examples." @default.
- W4383175803 created "2023-07-05" @default.
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- W4383175803 date "2023-06-30" @default.
- W4383175803 modified "2023-10-04" @default.
- W4383175803 title "A Direct Approach to Simultaneous Tests of Superiority and Noninferiority with Multiple Endpoints" @default.
- W4383175803 doi "https://doi.org/10.48550/arxiv.2307.00189" @default.
- W4383175803 hasPublicationYear "2023" @default.
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