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In a fixed-sample clinical trial, data on all individuals are analyzed at the end of the study. In contrast, a group sequential trial provides for interim analyses before completion of the trial. Thus, a group sequential trial is useful for preventing unnecessary exposure of patients to an unsafe new drug or to a placebo treatment if a new drug shows significant improvement. This paper reviews basic concepts of group sequential analysis and introduces two SAS/STAT procedures: the SEQDESIGN and SEQTEST procedures. Both procedures are experimental in SAS 9.2.

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Format:PDFSize:460 KB
Date:Mar 2009
Pages:20

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