Multiple testing to establish noninferiority of k treatments with a reference based on the ratio of two means
Multiple testing to establish noninferiority of k treatments with a reference based on the ratio of two means
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DOI：
10.1177/009286150103500421
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发表时间：
2001-10-01
影响因子：
--
通讯作者：
Kieser, M
中科院分区：
文献类型：
--
作者：
Hauschke, D;Kieser, M
大多数主动对照试验的目的是表明正在研究的治疗方法不比参考治疗方法劣于预先指定的临床无关量。在具有不止一种测试治疗的多组试验的情况下，可能需要证明所有这些组相对于参考组的非劣效性。或者，它可以足以证明至少一种测试处理相对于参考的非劣效性。这些临床问题对应于整体非劣效性和部分非劣效性的概念。对于这两种情况，都给出了非劣效性界限表示为未知参考平均值的比例的情况的测试程序。
It is the aim of most active control trials to show that the treatment(s) under investigation is (are) not inferior to the reference by more than a prespecified clinically irrelevant amount. In the situation of a multiarmed trial with more than one test treatment it may be required that noninferiority of all these groups to the reference be demonstrated. Alternatively, it may by sufficient to proved noninferiority of at least one of the test treatments to the reference. These clinical questions correspond to the concepts of global and partial noninferiority. For both scenarios test procedures are given for the situation that the noninferiority margin is expressed as a proportion of the unknown reference mean.