Journal
DRUG INFORMATION JOURNAL
Volume 46, Issue 6, Pages 647-656Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/0092861512454116
Keywords
subgroup analysis; tailored therapy; type I error rate; influence condition; interaction condition
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This article focuses on statistical analysis of clinical trials pursuing tailored therapy objectives, wherein evaluation of treatment effect occurs in the overall population as well as in a predefined subpopulation(s). The design and analysis principles presented provide a framework for decision making based on these novel multipopulation tailoring trial designs, considering the particular case of confirmatory trials. These principles include traditional multiple testing considerations, as well as 2 new analysis principles.
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