Yusuf S, Held P, Teo K K, Toretsky E R
Clinical Trials Branch, National Heart, Lung, and Blood Institute, Bethesda, MD 20892.
Stat Med. 1990 Jan-Feb;9(1-2):73-83; discussion 83-6. doi: 10.1002/sim.4780090114.
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.
本文讨论了影响随机对照试验患者入选的各种理念。尽管根据试验不同，需要考虑许多不同且常常相互冲突的问题，但通常最好保持入选标准简单、宽泛，有时甚至灵活。这样的策略可能具有积极的优点，有助于以合理的成本获得大量通常需要的患者，以便可靠地检测出可能存在的适度益处，并为患有特定疾病的许多不同类型患者提供相关答案。
