STATISTICAL INTERIM MONITORING OF THE CARDIAC-ARRHYTHMIA SUPPRESSION TRIAL

被引：26

作者：

PAWITAN, Y

HALLSTROM, A

机构：

[1] Department of Biostatistics Sc-32, University of Washington, Seattle, Washington

来源：

STATISTICS IN MEDICINE | 1990年 / 9卷 / 09期

关键词：

D O I：

10.1002/sim.4780090915

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

The Cardiac Arrythmia Suppression Trial was stopped much earlier than planned. Statistical considerations played a very important role in the decision. Flexible group sequential testing was developed for the trial by implementing a Lan and DeMets procedure with use of the permutation test. We compute P‐values from the joint permutation distribution of the test statistics, so we do not need to estimate the sampling distribution which in general is rather difficult to do without strict assumptions. The method also gives an exact test for small samples and allows us to use more complicated or non‐Gaussian statistics. We also utilized stochastic curtailment ideas to evaluate various scenarios that might occur during the course of the trial, which assisted the Data and Safety Monitoring Board in making appropriate decisions. Copyright © 1990 John Wiley & Sons, Ltd.

引用

页码：1081 / 1090

页数：10

共 14 条

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