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Response-adaptive clinical trials: case studies in the medical literature
Andrew P. Grieve,
Corresponding Author
Andrew P. Grieve
Innovation Centre, 3 Globeside Business Park, Marlow, Buckinghamshire, SL7 1HZ UK
Correspondence to: Andrew P. Grieve, Innovation Centre, Icon PLC,3 Globeside Business Park, Marlow, Buckinghamshire, SL7 1HZ, UK.
E-mail: [email protected]
Search for more papers by this authorAndrew P. Grieve,
Corresponding Author
Andrew P. Grieve
Innovation Centre, 3 Globeside Business Park, Marlow, Buckinghamshire, SL7 1HZ UK
Correspondence to: Andrew P. Grieve, Innovation Centre, Icon PLC,3 Globeside Business Park, Marlow, Buckinghamshire, SL7 1HZ, UK.
E-mail: [email protected]
Search for more papers by this authorAbstract
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.
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