Randomized play-the-winner clinical trials: Review and recommendations

被引：56

作者：

Rosenberger, WF

机构：

[1] Univ Maryland Baltimore Cty, Dept Math & Stat, Baltimore, MD 21250 USA

[2] Univ Maryland, Sch Med, Dept Epidemiol & Prevent Med, Baltimore, MD 21201 USA

来源：

CONTROLLED CLINICAL TRIALS | 1999年 / 20卷 / 04期

关键词：

adaptive designs; ethics in clinical trials; randomization; treatment allocation;

D O I：

10.1016/S0197-2456(99)00013-6

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 [基础医学];

摘要：

The randomized play-the-winner rule is an adaptive randomized design, based on an urn model, that is used occasionally in clinical trials. This paper discusses practical and theoretical issues arising from its use, including stratification, delayed response, operating characteristics, selection of um parameters, and inference. The paper also discusses recent experience with adaptive clinical trials within the pharmaceutical industry. The author concludes that the randomized play-the-winner rule is appropriate for some clinical trials, but intense and thoughtful planning must take place in the design phase. Such planning should incorporate considerations of variability, power, and appropriate techniques. Control Clin Trials 1999;20:328-342 (C) Elsevier Science Inc. 1999.

引用

页码：328 / 342

页数：15

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