Theoretical Medicine and Bioethics

, Volume 32, Issue 1, pp 61–74 | Cite as

Statistical decisions and the interim analyses of clinical trials



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.


Evidence Statistical inference Confirmation Bayesian Case study HIV/AIDS 


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Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  1. 1.Department of PhilosophyUniversity of British ColumbiaVancouverCanada

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