Methods for Equivalence and Noninferiority Testing

被引：93

作者：

da Silva, Gisela Tunes ^{[2
]}

Logan, Brent R. ^{[1
,3
]}

Klein, John P. ^{[1
,3
]}

机构：

[1] Med Coll Wisconsin, Div Biostat, Milwaukee, WI 53226 USA

[2] Univ Sao Paulo, Dept Stat, Sao Paulo, Brazil

[3] Med Coll Wisconsin, Ctr Int Blood & Marrow Transplant Res, Milwaukee, WI 53226 USA

来源：

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION | 2009年 / 15卷 / 01期

关键词：

Equivalence; Noninferiority; Hypothesis testing; Confidence intervals; Power; Survival; Odds ratio; Relative risk; NON-INFERIORITY TRIALS; CLINICAL-TRIALS; END-POINTS; STATISTICS; SURVIVAL; MODELS;

D O I：

10.1016/j.bbmt.2008.10.004

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Classical hypothesis testing focuses on testing whether treatments have differential effects on outcome. However, sometimes clinicians may be more interested in determining whether treatments are equivalent or whether one has noninferior outcomes. We review the hypotheses for these noninferiority and equivalence research questions, consider power and sample size issues, and discuss how to perform such a test for both binary and survival outcomes. The methods are illustrated on 2 recent studies in hematopoietic cell transplantation.

引用

页码：120 / 127

页数：8

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