Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands.
Stat Med. 2010 Sep 10;29(20):2117-25. doi: 10.1002/sim.4002.
We propose three-sided testing, a testing framework for simultaneous testing of inferiority, equivalence and superiority in clinical trials, controlling for multiple testing using the partitioning principle. Like the usual two-sided testing approach, this approach is completely symmetric in the two treatments compared. Still, because the hypotheses of inferiority and superiority are tested with one-sided tests, the proposed approach has more power than the two-sided approach to infer non-inferiority or non-superiority. Applied to the classical point null hypothesis of equivalence, the three-sided testing approach shows that it is sometimes possible to make an inference on the sign of the parameter of interest, even when the null hypothesis itself could not be rejected. Relationships with confidence intervals are explored, and the effectiveness of the three-sided testing approach is demonstrated in a number of recent clinical trials.
我们提出了三边检验，这是一种临床试验中同时检验劣势、等效和优势的检验框架，通过分区原理控制多重检验。与通常的双边检验方法一样，这种方法在比较的两种治疗方法中是完全对称的。然而，由于劣势和优势的假设是用单边检验进行检验，因此与双边方法相比，该方法在推断非劣势或非优势方面具有更高的功效。应用于经典的等效点零假设，三边检验方法表明，即使零假设本身不能被拒绝，有时也可以对感兴趣参数的符号进行推断。还探讨了与置信区间的关系，并在一些最近的临床试验中展示了三边检验方法的有效性。
