THE PROBLEM OF THERAPEUTIC EQUIVALENCE WITH PAIRED QUALITATIVE DATA - AN EXAMPLE FROM A CLINICAL-TRIAL USING HEMOPHILIACS WITH AN INHIBITOR TO FACTOR-VIII

被引：14

作者：

LEE, ML

LUSHER, JM

机构：

[1] Clinical Affairs, Trancel Corporation, Santa Ana, California

[2] Wayne State University School of Medicine, Detroit, Michigan

[3] UCLA School of Public Health, Division of Biostatistics, Los Angeles, California

[4] Department of Hematology, Children's Hospital of Michigan, Detroit, Michigan

来源：

STATISTICS IN MEDICINE | 1991年 / 10卷 / 03期

关键词：

D O I：

10.1002/sim.4780100315

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

The problem of demonstrating the equivalence of two treatments or drugs occurs fairly frequently in medicine, but is quite often misformulated. The common error is to assume equivalence is demonstrated if the usual null hypothesis of no difference is not rejected, which ignores the potential of a substantial beta-error. We describe here two procedures for testing equivalence when the data are paired and dichotomous, and provide sample size formulas. We give an example based on a clinical trial of haemophiliacs with inhibitor to Factor VIII.

引用

页码：433 / 441

页数：9

共 22 条

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