Statistical decisions and the interim analyses of clinical trials
- Roger Stanev
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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.
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- Statistical decisions and the interim analyses of clinical trials
Theoretical Medicine and Bioethics
Volume 32, Issue 1 , pp 61-74
- Cover Date
- Print ISSN
- Online ISSN
- Springer Netherlands
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- Statistical inference
- Case study
- Roger Stanev (1)
- Author Affiliations
- 1. Department of Philosophy, University of British Columbia, 1866 Main Mall E370, Vancouver, BC, V6T 1Z1, Canada