• Biom J · Aug 2008

    Review

    Group sequential and adaptive designs - a review of basic concepts and points of discussion.

    • Marc Vandemeulebroecke.
    • Novartis Pharma AG, Novartis Campus, 4056 Basel, Switzerland. marc.vandemeulebroecke@novartis.com
    • Biom J. 2008 Aug 1; 50 (4): 541-57.

    AbstractIn 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 ease 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.(c) 2008 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim

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