SELECTION OF PATIENTS FOR RANDOMIZED CONTROLLED TRIALS - IMPLICATIONS OF WIDE OR NARROW ELIGIBILITY CRITERIA

被引:78
作者
YUSUF, S
HELD, P
TEO, KK
TORETSKY, ER
机构
[1] Clinical Trials Branch, Division of Epidemiology and Clinical Application, National Heart, Lung, and Blood Institute, Bethesda, Maryland
[2] Collaborative Studies Coordinating Center, Department of Biostatistics, University of North Carolina, Chapel Hill, North Carolina
关键词
D O I
10.1002/sim.4780090114
中图分类号
Q [生物科学];
学科分类号
07 ; 0710 ; 09 ;
摘要
This paper discusses the various philosophies that influence the selection of patients for entry into randomized controlled trials. Although a number of different and often competing issues have to be considered depending upon the trial, keeping entry criteria simple, wide and at times even flexible is usually preferable. Such a strategy can be a positive virtue by helping to attain the large numbers of patients that are usually needed to reliably detect the sorts of moderate benefits that are plausible, at a reasonable cost and by providing answers that are relevant to many different categories of patients with a particular condition. Copyright © 1990 John Wiley & Sons, Ltd.
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页码:73 / 86
页数:14
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