Theoretical Medicine and Bioethics

, Volume 32, Issue 1, pp 61–74

Statistical decisions and the interim analyses of clinical trials

Authors

    • Department of PhilosophyUniversity of British Columbia
Article

DOI: 10.1007/s11017-010-9170-9

Cite this article as:
Stanev, R. Theor Med Bioeth (2011) 32: 61. doi:10.1007/s11017-010-9170-9

Abstract

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.

Keywords

EvidenceStatistical inferenceConfirmationBayesianCase studyHIV/AIDS

Copyright information

© Springer Science+Business Media B.V. 2011