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Stat Med. 1990 Jan-Feb;9(1-2):73-83; discussion 83-6.

Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria.

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Clinical Trials Branch, National Heart, Lung, and Blood Institute, Bethesda, MD 20892.


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.

[Indexed for MEDLINE]

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