期刊
CONTEMPORARY CLINICAL TRIALS
卷 28, 期 4, 页码 451-458出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2006.11.003
关键词
center effect; intraclass correlation coefficient; multicenter randomized trial; sample size
In multicenter trials, data from the same center are more similar than those from different centers. These similarities induce a correlation between data, known as the center effect, which is assessed by the intraclass correlation coefficient (ICC). Here, we derive a sample size formula for continuous data that takes into account this center effect. Our analytical developments lead to an elementary formula different from the classical one by a (1-rho) factor, where rho is the ICC. This work allows for adjusting and reducing the sample size according to the magnitude of the center effect and leads to a better consistency in the conduct of multicenter randomized trials. (c) 2006 Elsevier Inc. All rights reserved.
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