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Sample size determination for group sequential clinical trials with immediate response
Author(s) -
Kim Kyungmann,
Demets David L.
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.4780111012
Subject(s) - sample size determination , sequential analysis , computer science , function (biology) , protocol (science) , group (periodic table) , sample (material) , type i and type ii errors , statistics , mathematics , medicine , chemistry , alternative medicine , organic chemistry , pathology , chromatography , evolutionary biology , biology
The use function approach to group sequential methods has been explored previously. Any group sequential design requires specifying the frequency and times of repeated analyses, but only the use function approach allows deviations from those specified in the design, without affecting the type I error in the analysis. This paper illustrates how the use function provides a simple and flexible design procedure and how the initially projected maximum sample size can be calculated for randomized clinical trials in which responses are known relatively soon after patient entry and for which there is an early stopping rule built into the study protocol. Also the consequence of using the proposed design procedure is investigated in terms of the operating characteristics of the subsequent group sequential analyses.