Testing of non-inferiority and superiority for three-arm clinical studies with multiple experimental treatments

Junjiang Zhong, Miin-Jye Wen, Koon Shing Kwong, Siu Hung Cheung

研究成果: Article

4 引文 斯高帕斯(Scopus)

摘要

The purpose of a non-inferiority trial is to assert the efficacy of an experimental treatment compared with a reference treatment by showing that the experimental treatment retains a substantial proportion of the efficacy of the reference treatment. Statistical methods have been developed to test multiple experimental treatments in three-arm non-inferiority trials. In this paper, we report the development of procedures that simultaneously test the non-inferiority and the superiority of experimental treatments after the assay sensitivity has been established. The advantage of the proposed test procedures is the additional ability to identify superior treatments while retaining an non-inferiority testing power comparable to that of existing testing procedures. Single-step and stepwise procedures are derived and then compared with each other to determine their relative testing power and testing error in a simulation study. Finally, the suggested procedures are illustrated with two clinical examples.

原文English
頁(從 - 到)1751-1765
頁數15
期刊Statistical Methods in Medical Research
27
發行號6
DOIs
出版狀態Published - 2018 六月 1

    指紋

All Science Journal Classification (ASJC) codes

  • Epidemiology
  • Statistics and Probability
  • Health Information Management

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