A SEQUENTIAL PHASE-II/III TRIAL FOR BINARY OUTCOMES

被引：18

作者：

STORER, BE

机构：

[1] Departments of Statistics and Human Oncology, University of Wisconsin, Medical Science Center, Madison, Wisconsin, 53706

来源：

STATISTICS IN MEDICINE | 1990年 / 9卷 / 03期

关键词：

D O I：

10.1002/sim.4780090305

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

This paper describes a simple two‐stage design for randomized clinical trials with a binary outcome. An early stopping criterion applies to results in the experimental arm only and seeks to evaluate that arm with respect to some external standard of efficacy. Stopping rules are similar to those commonly used in phase II designs. This design has no adverse impact on the overall type I error rate, though one must increase sample size to accommodate a modest loss in power. Copyright © 1990 John Wiley & Sons, Ltd.

引用

页码：229 / 235

页数：7

共 7 条

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