METHODOLOGICAL STANDARDS FOR ASSESSING THERAPEUTIC EQUIVALENCE

被引：19

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
BLOCK, PC
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 1988, 319 (03) : 169 - 171
[4] NULL RESULTS IN CLINICAL-TRIALS - THE NEED FOR A DECISION-THEORY APPROACH
CIAMPI, A
TILL, JE
[J]. BRITISH JOURNAL OF CANCER, 1980, 41 (04) : 618 - 629
[5] Cohen J, 1977, STAT POWER ANAL BEHA
[6] ESTABLISHING THERAPEUTIC EQUIVALENCY - WHAT IS A CLINICALLY SIGNIFICANT DIFFERENCE
DETSKY, AS
SACKETT, DL
[J]. ARCHIVES OF INTERNAL MEDICINE, 1986, 146 (05) : 861 - 862
[7] SIGNIFICANCE TESTING TO ESTABLISH EQUIVALENCE BETWEEN TREATMENTS, WITH SPECIAL REFERENCE TO DATA IN FORM OF 2 X 2 TABLES
DUNNETT, CW
GENT, M
[J]. BIOMETRICS, 1977, 33 (04) : 593 - 602
[8] FLETCHER RH, 1982, CLIN EPIDEMIOLOGY ES, P21
[9] IMPORTANCE OF BETA, TYPE-II ERROR AND SAMPLE-SIZE IN DESIGN AND INTERPRETATION OF RANDOMIZED CONTROL TRIAL - SURVEY OF 71 NEGATIVE TRIALS
FREIMAN, JA
CHALMERS, TC
SMITH, H
KUEBLER, RR
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 1978, 299 (13) : 690 - 694
[10] CONFIDENCE-INTERVALS RATHER THAN P-VALUES - ESTIMATION RATHER THAN HYPOTHESIS-TESTING
GARDNER, MJ
ALTMAN, DG
[J]. BMJ-BRITISH MEDICAL JOURNAL, 1986, 292 (6522): : 746 - 750

← 1 2 3 →