Theoretical Medicine and Bioethics 32 (1):61-74 (2011)
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)|
References found in this work BETA
Principles of Early Stopping of Randomized Trials for Efficacy: A Critique of Equipoise and an Alternative Nonexploitation Ethical Framework.David Buchanan & Franklin G. Miller - 2005 - Kennedy Institute of Ethics Journal 15 (2):161-178.
Citations of this work BETA
Early Stopping of RCTs: Two Potential Issues for Error Statistics.Roger Stanev - 2015 - Synthese 192 (4):1089-1116.
Similar books and articles
The Children's Oncology Group Routinely Applies “Lack of Efficacy” Interim Monitoring to Its Randomized Clinical Trials.James R. Anderson & Mark Krailo - 2011 - American Journal of Bioethics 11 (3):18-19.
The Use of Interval Estimators as a Basis for Decision-Making in Medicine.Reidar K. Lie - 1984 - Theoretical Medicine and Bioethics 5 (3).
The Research Misconception.Maurie Markman - 2004 - International Journal of Applied Philosophy 18 (2):241-252.
Human Experimentation: A Guided Step Into the Unknown.William A. Silverman - 1985 - Oxford University Press.
What Makes Placebo-Controlled Trials Unethical?Franklin G. Miller & Howard Brody - 2002 - American Journal of Bioethics 2 (2):3 – 9.
Progress Toward a More Ethical Method for Clinical Trials.Joseph B. Kadane - 1986 - Journal of Medicine and Philosophy 11 (4):385-404.
Inefficacy Interim Monitoring Procedures in Randomized Clinical Trials: The Need to Report.Boris Freidlin & Edward L. Korn - 2011 - American Journal of Bioethics 11 (3):2-10.
Uncertainty and the Ethics of Clinical Trials.Sven Ove Hansson - 2006 - Theoretical Medicine and Bioethics 27 (2):149-167.
Early Stopping of Clinical Trials: Charting the Ethical Terrain.Malmqvist Erik, Juth Niklas, Lynöe Niels & Helgesson Gert - 2011 - Kennedy Institute of Ethics Journal 21 (1):51-78.
Stopping Rules and Data Monitoring in Clinical Trials.Roger Stanev - 2012 - 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. pp. 375--386.
Added to index2009-11-18
Total downloads98 ( #51,248 of 2,158,886 )
Recent downloads (6 months)2 ( #193,038 of 2,158,886 )
How can I increase my downloads?