Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 22, Issue 4, Pages 719-736Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2012.676535
Keywords
Adaptive designs; Delayed response; Optimal allocation; Sequential analysis
Categories
Funding
- National Science Foundation (USA) [DMS-0907297, DMS-0906661]
- National Science Foundation [DMS-0904253]
- Direct For Mathematical & Physical Scien
- Division Of Mathematical Sciences [0907297] Funding Source: National Science Foundation
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In February 2010, the U.S. Food and Drug Administration (FDA, 2010) drafted guidance that discusses the statistical, clinical, and regulatory aspects of various adaptive designs for clinical trials. An important class of adaptive designs is adaptive randomization, which is considered very briefly in subsection VI.B of the guidance. The objective of this paper is to review several important new classes of adaptive randomization procedures and convey information on the recent developments in the literature on this topic. Much of this literature has been focused on the development of methodology to address past criticisms and concerns that have hindered the broader use of adaptive randomization. We conclude that adaptive randomization is a very broad area of experimental design that has important application in modern clinical trials.
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