Document Detail


Statistical decisions and the interim analyses of clinical trials.
MedLine Citation:
PMID:  21222041     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
This paper analyzes statistical decisions during the interim analyses of clinical trials. After some general remarks about the ethical and scientific demands of clinical trials, I introduce the notion of a hard-case clinical trial, explain the basic idea behind it, and provide a real example involving the interim analyses of zidovudine in asymptomatic HIV-infected patients. The example leads me to propose a decision analytic framework for handling ethical conflicts that might arise during the monitoring of hard-case clinical trials. I use computer simulations to show how the framework can assist in reconciling certain ethical conflicts. The framework is partial, lacking the precision of a complete systematization of statistical monitoring procedures in practice.
Authors:
Roger Stanev
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Theoretical medicine and bioethics     Volume:  32     ISSN:  1573-0980     ISO Abbreviation:  Theor Med Bioeth     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-24     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9805378     Medline TA:  Theor Med Bioeth     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  61-74     Citation Subset:  E; IM    
Affiliation:
Department of Philosophy, University of British Columbia, 1866 Main Mall E370, Vancouver, BC, V6T 1Z1, Canada, rstanev@interchange.ubc.ca.
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