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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
Issue
Pages 353-364
Publisher
Link_for_PDF_for_Education
Link for Open Access
DOI
Link for DOI
Web_Access_Paper http://www.ncbi.nlm.nih.gov/pubmed/11697227
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.
Additional_Information
Reference_Subject Biostat_Ethics
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Topic revision: 12 Mar 2013, MaryBanach
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