Journal
PHARMACEUTICAL STATISTICS
Volume 16, Issue 1, Pages 64-86Publisher
WILEY
DOI: 10.1002/pst.1778
Keywords
drug development; clinical trials; response ADs; up-and-down; biased coin; play-the-winner; randomised play-the-winner; 3+3; continual reassessment method; Bayesian
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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 (C) 2016 John Wiley & Sons, Ltd.
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