Statistical decisions and the interim analyses of clinical trials


Authors
Roger Stanev
University of Ottawa
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 Evidence  Statistical inference  Confirmation  Bayesian  Case study  HIV/AIDS
Categories (categorize this paper)
DOI 10.1007/s11017-010-9170-9
Options
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

Our Archive


Upload a copy of this paper     Check publisher's policy     Papers currently archived: 42,993
Through your library

References found in this work BETA

Add more references

Citations of this work BETA

Data and Safety Monitoring Board and the Ratio Decidendi of the Trial.Roger Stanev - 2015 - Journal of Philosophy, Science and Law 15:1-26.

Add more citations

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.

Analytics

Added to PP index
2009-11-18

Total views
104 ( #75,377 of 2,259,536 )

Recent downloads (6 months)
1 ( #911,962 of 2,259,536 )

How can I increase my downloads?

Downloads

My notes

Sign in to use this feature