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Title Adaptive designs for binary treatment responses in phase III clinical trials: controversies and progress
Author Atanu Biswas
Year 2001
Journal Statistical Methods in Medical Research
Volume 10
Pages 353-364
Link for Open Access
Link for DOI
Contributed_by John Lantos, KU/Frontiers
Commentary This is a review of the controversies surrounding the use of adaptive study designs (i.e. play-the-winner randomizations) in clinical trials. It advocates wider use of such designs in order to minimize the number of patients who are randomly assigned to the treatment that turns out to be inferior. It is fairly balanced, though, in its examination of the controversies. It reviews the details of two such trials - Bartlett's Michigan ECMO trial and a large study published by Tumura et al of antidepressant medication. These study designs raise interesting ethical issues about the tensions between scientific rigor and the desire to minimize risks to human subjects.
Reference_Subject Biostat_Ethics
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