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Interim analyses for monitoring clinical trials that do not materially affect the type I error rate
Author(s) -
Gould A. Lawrence
Publication year - 1992
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.4780110107
Subject(s) - interim , type i and type ii errors , sample size determination , binomial distribution , null hypothesis , statistics , interim analysis , computer science , protocol (science) , statistical power , clinical trial , econometrics , mathematics , medicine , alternative medicine , archaeology , pathology , history
Monitoring 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.