Statistical decisions and the interim analyses of clinical trials
- Roger Stanev
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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.
- Idänpään-Heikkilä, J., and Sev Fluss. 2005. Emerging international norms for clinical testing. In Ethics and the pharmaceutical industry, ed. M.A. Santoro and T.M. Gorrie, 37–47. Cambridge: Cambridge University Press.
- Epstein, S. 1996. Impure science–AIDS, activism, and the politics of knowledge. Berkeley, CA: University of California Press.
- Petryna, A. 2009. When experiments travel. Princeton, NJ: Princeton University Press.
- Hawkins, J.S., and E.J. Emanuel, eds. 2008. Exploitation and developing countries: The ethics of clinical research. Princeton, NJ: Princeton University Press.
- Cannistra, S.A. 2004. The ethics of early stopping rules: Who is protecting whom? Journal of Clinical Oncology 22: 1542–1545. CrossRef
- Buchanan, D., and F. Miller. 2005. Principles of early stopping of randomized trials of efficacy: A critique of equipoise and an alternative nonexploitation ethical framework. Kennedy Institute of Ethics Journal 15: 161–178. CrossRef
- Merigan, T.C. 1990. You can teach an old dog new tricks: How AIDS trials are pioneering new strategies. New England Journal of Medicine 323(19): 1341–1343. CrossRef
- Pocock, S. 1993. Statistical and ethical issues in monitoring clinical trials. Statistics in Medicine 12: 1459–1469. CrossRef
- Volberding, P.A., S.W. Lagakos, M.A. Koch, et al. 1990. Zidovudine in asymptomatic human immunodeficiency virus infection. New England Journal of Medicine 322: 941–949. CrossRef
- Concorde Coordinating Committee. 1994. Corcorde: MRC/ANRS randomised double-blind controlled trail of immediate and deferred zidovudine in symptom-free HIV infection. Lancet 343(8902): 871–881. CrossRef
- Ellenberg, S. 2003. Are all monitoring boundaries equally ethical? Controlled Clinical Trials 24: 585–588. CrossRef
- Statistical decisions and the interim analyses of clinical trials
Theoretical Medicine and Bioethics
Volume 32, Issue 1 , pp 61-74
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- Springer Netherlands
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- Statistical inference
- Case study
- Roger Stanev (1)
- Author Affiliations
- 1. Department of Philosophy, University of British Columbia, 1866 Main Mall E370, Vancouver, BC, V6T 1Z1, Canada