title: The futility study--Progress over the last decade.
abstract: We review the futility clinical trial design (also known as the non-superiority design) with respect to its emergence and methodologic developments over the last decade, especially in regard to its application to clinical trials for neurological disorders. We discuss the design's strengths as a programmatic screening device to weed out unpromising new treatments, its limitations and pitfalls, and a recent critique of the logic of the method.
authors.affiliation: Department of Biostatistics, Columbia University, New York, NY 10032, United States. Electronic address: Bruce.Levin@Columbia.edu.
authors.forename: Bruce
authors.initials: B
authors.lastname: Levin
mesh_terms: D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D006801:Humans; D015233:Models, Statistical; D009422:Nervous System Diseases / Q000188:drug therapy; D012107:Research Design
keywords: Futility design; Non-superiority design; Phase II trials; Screening program