title: Response-adaptive clinical trials: case studies in the medical literature.
abstract: The past 15 years has seen many pharmaceutical sponsors consider and implement adaptive designs (AD) across all phases of drug development. Given their arrival at the turn of the millennium, we might think that they are a recent invention. That is not the case. The earliest idea of an AD predates Bradford Hill's MRC tuberculosis study, appearing in Biometrika in 1933. In this paper, we trace the development of response-ADs, designs in which the allocation to intervention arms depends on the responses of subjects already treated. We describe some statistical details underlying the designs, but our main focus is to describe and comment on ADs from the medical research literature. Copyright © 2016 John Wiley & Sons, Ltd.
authors.affiliation: Innovation Centre, 3 Globeside Business Park, Marlow, Buckinghamshire, SL7 1HZ, UK.
authors.forename: Andrew P
authors.identifier: 0000-0003-3143-2554
authors.initials: AP
authors.lastname: Grieve
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003627:Data Interpretation, Statistical; D015195:Drug Design; D004345:Drug Industry / Q000379:methods; D006801:Humans; D012107:Research Design
keywords: 3+3; Bayesian; biased coin; clinical trials; continual reassessment method; drug development; play-the-winner; randomised play-the-winner; response ADs; up-and-down