Easy Multiplicity Control in Equivalence Testing Using Two One-Sided Tests
Easy Multiplicity Control in Equivalence Testing Using Two One-Sided Tests
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DOI：
10.1198/tast.2009.0029
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发表时间：
2009-05-01
影响因子：
1.8
通讯作者：
Caffo, Brian
中科院分区：
文献类型：
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作者：
Lauzon, Carolyn;Caffo, Brian
等效性测试在科学研究中的应用越来越多，超出了其在药物审批过程中的传统作用。很大程度上由于其易用性以及美国食品和药物管理局指南的建议，用于测试等效性的最常见统计方法是两个单侧测试 (TOST) 程序。与经典的零点假设检验一样，随着进行更多的比较，TOST 也会受到多重性问题的影响。在这里，我们使用 TOST 给出了限制族错误率 (FWER) 的条件，并得出控制 FWER 的简单解决方案。具体来说，我们证明，如果对 k 个独立组的所有成对比较进行等效性评估，则只需将标称 I 类错误率降低 (k - 1) 就足以将 FWER 维持在所需值或更低。由此产生的规则比同样简单的 Bonferroni 校正要保守得多。给出了非药物开发环境中的等效性测试的示例。
The use of equivalence testin g in scientific research is increasing beyond its traditional role in the drug approval process. Largely due to its ease Of use and recommendations from the U.S. Food and Drug Administration guidance, the most common statistical method for testing equivalence is the two one-sided tests (TOST) procedure. Like classical point-null hypothesis testing, TOST is subject to multiplicity concerns as more comparisons are made. Here we give a condition that bounds the familywise error rate (FWER) Using TOST and leads to a simple solution for controlling the FWER. Specifically, we demonstrate that if all pairwise comparisons of k independent groups are being evaluated for equivalence, then simply scaling the nominal type I error rate down by (k - 1) is Sufficient to maintain the FWER at the desired value or less. The resulting rule is much less conservative than the equally simple Bonferroni correction. An example of equivalence testing in a non-drug development setting is given.