Statistical decisions and the interim analyses of clinical trials

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.

Download options

PhilArchive



    Upload a copy of this work     Papers currently archived: 72,694

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Analytics

Added to PP
2009-11-18

Downloads
106 (#113,372)

6 months
1 (#388,319)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Roger Stanev
University of Ottawa

Similar books and articles

Uncertainty and the Ethics of Clinical Trials.Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167.
Progress Toward a More Ethical Method for Clinical Trials.Joseph B. Kadane - 1986 - Journal of Medicine and Philosophy 11 (4):385-404.
What Makes Placebo-Controlled Trials Unethical?Franklin G. Miller & Howard Brody - 2002 - American Journal of Bioethics 2 (2):3 – 9.
The Research Misconception.Maurie Markman - 2004 - International Journal of Applied Philosophy 18 (2):241-252.