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 |
Disclaimer | The views expressed within CTSpedia are those of the author and must not be taken to represent policy or guidance on the behalf of any organization or institution with which the author is affiliated. |