Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria.
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.
Yusuf
S
S
Clinical Trials Branch, National Heart, Lung, and Blood Institute, Bethesda, MD 20892.
Held
P
P
Teo
K K
KK
Toretsky
E R
ER
D015982:Bias; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D015983:Selection Bias