title: Group sequential and adaptive designs - a review of basic concepts and points of discussion.
abstract: 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 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.
authors.affiliation: Novartis Pharma AG, Novartis Campus, 4056 Basel, Switzerland. marc.vandemeulebroecke@novartis.com
authors.forename: Marc
authors.initials: M
authors.lastname: Vandemeulebroecke
mesh_terms: D000465:Algorithms; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D015203:Reproducibility of Results