A useful testing strategy in phase III trials: combined test of superiority and test of equivalence.
A useful testing strategy in phase III trials: combined test of superiority and test of equivalence.
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DOI：
10.1080/10543409508835115
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发表时间：
1995-11-01
影响因子：
1.1
通讯作者：
Yoshida, M
中科院分区：
文献类型：
--
作者：
Morikawa, T;Yoshida, M
一个有用的测试策略，提出了一个确证性III期临床试验。该方法由优效性检验和等效性检验相结合的方法组成，易于应用。通过引入该策略，我们可以在验证性实验中进行事后分析。因此，比通常的单一测试方法提供更灵活的决定是可能的。它表明，该程序不需要调整的多重性从封闭的测试程序的角度来看。本文还讨论了这种策略与置信区间的关系。
A useful testing strategy is proposed for a confirmatory phase III clinical trial. It consists of a combined test of superiority and test of equivalence, and it is easy to apply. By introducing the strategy, we can perform a post hoc analysis in a confirmatory experiment. Thus a more flexible decision will be possible than the usual single testing method provides. It is shown that the procedure needs no adjustment for multiplicity from the point of view of the closed testing procedure. The relationship between this strategy and a confidence interval is also discussed.