David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
Journal of Experimental and Theoretical Artificial Intelligence 24 (4):513-526 (2012)
Despite efforts from regulatory agencies (e.g. NIH, FDA), recent systematic reviews of randomised controlled trials (RCTs) show that top medical journals continue to publish trials without requiring authors to report details for readers to evaluate early stopping decisions carefully. This article presents a systematic way of modelling and simulating interim monitoring decisions of RCTs. By taking an approach that is both general and rigorous, the proposed framework models and evaluates early stopping decisions of RCTs based on a clear and consistent set of criteria. The framework allows decision analysts to generate and quickly answer ‘what-if’ questions by simulating alternate trial scenarios. I illustrate the framework with a case study of an RCT that was stopped early due to harm. This was a trial of vitamin A supplement in relation to HIV transmission from mother-to-child through breastfeeding.
|Keywords||computer modeling and simulation statistical evidence and inference decision theory counterfactual reasoning Bayesian methods randomized controlled trials technology|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Roger Stanev (2012). The Epistemology and Ethics of Early Stopping Decisions in Randomized Controlled Trials. Dissertation, University of British Columbia
Roger Stanev (2011). Statistical Decisions and the Interim Analyses of Clinical Trials. Theoretical Medicine and Bioethics 32 (1):61-74.
Cecilia Nardini & Jan Sprenger (2014). Bias and Conditioning in Sequential Medical Trials. Philosophy of Science 80 (5):1053-1064.
David Buchanan & Franklin G. Miller (2005). Principles of Early Stopping of Randomized Trials for Efficacy: A Critique of Equipoise and an Alternative Nonexploitation Ethical Framework. Kennedy Institute of Ethics Journal 15 (2):161-178.
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. 375--386.
David Teira (2011). Bayesian Versus Frequentist Clinical Trials. In Gifford Fred (ed.), Philosophy of Medicine [Handbook of Philosophy of Science, vol. 16],. Elsevier.
David J. Torgerson & Carole J. Torgerson (2003). Avoiding Bias in Randomised Controlled Trials in Educational Research. British Journal of Educational Studies 51 (1):36 - 45.
Robyn Bluhm (2009). Some Observations on “Observational” Research. Perspectives in Biology and Medicine 52 (2):252-263.
Bridget Haire, John Kaldor & Christopher Fc Jordens (2012). How Good Is “Good Enough”? The Case for Varying Standards of Evidence According to Need for New Interventions in HIV Prevention. American Journal of Bioethics 12 (6):21-30.
Lisa R. Stines & Norah C. Feeny (2008). Unique Ethical Concerns in Clinical Trials Comparing Psychosocial and Psychopharmalogical Interventions. Ethics and Behavior 18 (2 & 3):234 – 246.
Fred Gifford (1986). The Conflict Between Randomized Clinical Trials and the Therapeutic Obligation. Journal of Medicine and Philosophy 11 (4):347-366.
Franklin G. Miller & Howard Brody (2007). Clinical Equipoise and the Incoherence of Research Ethics. Journal of Medicine and Philosophy 32 (2):151 – 165.
Loretta Kopelman (1986). Consent and Randomized Clinical Trials: Are There Moral or Design Problems? Journal of Medicine and Philosophy 11 (4):317-345.
Nancy Cartwright (2010). What Are Randomised Controlled Trials Good For? Philosophical Studies 147 (1):59 - 70.
Added to index2012-09-06
Total downloads10 ( #148,332 of 1,102,717 )
Recent downloads (6 months)1 ( #296,833 of 1,102,717 )
How can I increase my downloads?