Graduate studies at Western
Theoretical Medicine and Bioethics 32 (1):61-74 (2011)
|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)|
|Through your library||Configure|
Similar books and articles
James R. Anderson & Mark Krailo (2011). The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials. American Journal of Bioethics 11 (3):18-19.
Erik Malmqvist, Niklas Juth, Niels Lynöe & Gert Helgesson (2011). Early Stopping of Clinical Trials: Charting the Ethical Terrain. Kennedy Institute of Ethics Journal 21 (1):51-78.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Boris Freidlin & Edward L. Korn (2011). Inefficacy Interim Monitoring Procedures in Randomized Clinical Trials: The Need to Report. American Journal of Bioethics 11 (3):2-10.
Joseph B. Kadane (1986). Progress Toward a More Ethical Method for Clinical Trials. Journal of Medicine and Philosophy 11 (4):385-404.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
William A. Silverman (1985). Human Experimentation: A Guided Step Into the Unknown. Oxford University Press.
Maurie Markman (2004). The Research Misconception. International Journal of Applied Philosophy 18 (2):241-252.
Reidar K. Lie (1984). The Use of Interval Estimators as a Basis for Decision-Making in Medicine. Theoretical Medicine and Bioethics 5 (3).
Roger Stanev (2012). Stopping Rules and Data Monitoring in Clinical Trials. In H. W. de Regt, S. Hartmann & S. Okasha (eds.), EPSA Philosophy of Science: Amsterdam 2009, The European Philosophy of Science Association Proceedings Vol. 1, 375-386. Springer.
Added to index2009-11-18
Total downloads49 ( #25,810 of 722,947 )
Recent downloads (6 months)1 ( #61,087 of 722,947 )
How can I increase my downloads?