METHODOLOGICAL STANDARDS FOR ASSESSING THERAPEUTIC EQUIVALENCE

被引：20

作者：

KIRSHNER, B

机构：

[1] Peel Health Department, Brampton, Ont. L6W 4P3

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 1991年 / 44卷 / 08期

关键词：

EQUIVALENCE; CRITICAL APPRAISAL; CLINICAL TRIAL; EFFECTIVENESS; PRECISION; VALIDITY; TYPE-I AND TYPE-II ERROR; CLINICAL-TRIALS; DESIGN; ISSUES;

D O I：

10.1016/0895-4356(91)90139-Z

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

This paper reviews issues related to defining and demonstrating therapeutic equivalence. A set of guidelines are proposed to critically review clinical trials to determine whether there is sufficient evidence to conclude that an experimental therapy is therapeutically equivalent to a standard one. These guidelines include criteria for assessing whether imprecision pertaining to the measurement of outcomes impinges on the validity of an equivalence test.

引用

页码：839 / 849

页数：11

共 22 条

[1]

[Anonymous], 1982, Epidemiologic Research: Principles and Quantitative Methods

[2]

BLACKWELDER WC, 1982, CONTR CLIN TRIALS, V5, P97

[3] AORTIC VALVULOPLASTY - A VALID ALTERNATIVE [J].