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Interim analyses for monitoring clinical trials that do not materially affect the type I error rate

 

作者: A. Lawrence Gould,  

 

期刊: Statistics in Medicine  (WILEY Available online 1992)
卷期: Volume 11, issue 1  

页码: 55-66

 

ISSN:0277-6715

 

年代: 1992

 

DOI:10.1002/sim.4780110107

 

出版商: Wiley Subscription Services, Inc., A Wiley Company

 

数据来源: WILEY

 

摘要:

AbstractMonitoring clinical trials often requires examining the interim findings to see if the sample size originally specified in the protocol will provide the required power against the null hypothesis when the alternative hypothesis is true, and to increase the sample size if necessary. This paper presents a new method, based on the overall response rate, for carrying out interim power evaluations when the observations have binomial distributions, without unblinding the treatment assignments or materially affecting the type I error rate. Simulation study results confirm the performance of the method.

 

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