Dunnett C W, Tamhane A C
Department of Mathematics and Statistics, McMaster University, Hamilton, Ontario, Canada.
Stat Med. 1997 Nov 15;16(21):2489-506. doi: 10.1002/(sici)1097-0258(19971115)16:21<2489::aid-sim684>3.0.co;2-d.
In this paper we develop multiple hypotheses testing procedures to compare a new treatment with a set of standard treatments in a clinical trial. The aim is to classify the new treatment with respect to each of the standards, by specifying those to which the new treatment is superior, those to which the new treatment is equivalent and those to which one can establish neither superiority nor equivalence. We propose several stepwise procedures and compare them with respect to their familywise error rates and power. The step-down methods SD1 and SD2 test for superiority first, followed by tests for equivalence for those comparisons where we cannot establish superiority. The step-up methods SU1 and SU2 test for equivalence first, followed by tests for superiority for those comparisons where we can establish at least equivalence. The methods SD3 and SU3 apply the tests for superiority and equivalence in pairs. All the methods require that we specify a threshold value delta > 0 in advance for defining equivalence. In applications where it is not possible to specify a value delta, we can use the method SD1 by testing for superiority first, followed by one-sided confidence limits on the efficacy differences for those comparisons where we cannot establish superiority.
在本文中，我们开发了多种多重假设检验程序，用于在临床试验中将一种新疗法与一组标准疗法进行比较。目的是根据每种标准对新疗法进行分类，具体指明新疗法优于哪些标准疗法、与哪些标准疗法等效，以及哪些既不能确定其优越性也不能确定其等效性。我们提出了几种逐步检验程序，并就其族系错误率和检验功效对它们进行比较。逐步下调方法SD1和SD2首先检验优越性，然后对那些无法确定优越性的比较进行等效性检验。逐步上调方法SU1和SU2首先检验等效性，然后对那些至少能确定等效性的比较进行优越性检验。方法SD3和SU3成对应用优越性检验和等效性检验。所有方法都要求我们预先指定一个阈值δ>0来定义等效性。在无法指定δ值的应用中，我们可以先使用方法SD1检验优越性，然后对那些无法确定优越性的比较给出疗效差异的单侧置信限。
