期刊
BIOMETRICAL JOURNAL
卷 50, 期 4, 页码 541-557出版社
WILEY
DOI: 10.1002/bimj.200710436
关键词
adaptive design; combination test; conditional error function; flexible design; group sequential design; interim analysis; sequential analysis; spending function; trial integrity; trial validity
In recent times, group sequential and adaptive designs for clinical trials have attracted great attention from industry, academia and regulatory authorities. These designs allow analyses on accumulating data - as opposed to classical, fixed-sample statistics. The rapid development of a great variety of statistical procedures is accompanied by a lively debate on their potential merits and shortcomings. The purpose of this review article is to case orientation in both respects. First, we provide a concise overview of the essential technical concepts, with special emphasis on their interrelationships. Second, we give a structured review of the current controversial discussion on practical issues, opportunities and challenges of these new designs.
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