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 (2005)
|Abstract||: Recent controversial decisions to terminate several large clinical trials have called attention to the need for developing a sound ethical framework to determine when trials should be stopped in light of emerging efficacy data. Currently, the fundamental rationale for stopping trials early is based on the principle that equipoise has been disturbed. We present an analysis of the ethical and practical problems with the "equipoise disturbed" position and describe an alternative ethical framework based on the principle of nonexploitation. This framework acknowledges the need for balancing the dual ethical obligations of clinical research, the protection of human subjects and the generation of new medical knowledge. Based on this framework, we put forward a proposal to make early stopping guidelines more stringent under specified conditions. The temporary withholding of apparent benefits in certain circumstances is justified by achieving a fair contract with the research participants, one that protects them from undue harm and exploitation while reducing the many uncertainties surrounding new investigational treatments that arise when trials are stopped prematurely|
|Keywords||No keywords specified (fix it)|
|Through your library||Configure|
Similar books and articles
Roger Stanev (2011). Statistical Decisions and the Interim Analyses of Clinical Trials. Theoretical Medicine and Bioethics 32 (1):61-74.
Robert M. Veatch (2002). Indifference of Subjects: An Alternative to Equipoise in Randomized Clinical Trials. Social Philosophy and Policy 19 (2):295-323.
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.
Sven Ove Hansson (2006). Uncertainty and the Ethics of Clinical Trials. Theoretical Medicine and Bioethics 27 (2):149-167.
Franklin G. Miller & Howard Brody (2002). What Makes Placebo-Controlled Trials Unethical? American Journal of Bioethics 2 (2):3 – 9.
Douglas E. Schlichting (2010). Destabilizing the 'Equipoise' Framework in Clinical Trials: Prioritizing Non-Exploitation as an Ethical Framework in Clinical Research. Nursing Philosophy 11 (4):271-279.
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.
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).
Fred Gifford (2007). Pulling the Plug on Clinical Equipoise: A Critique of Miller and Weijer. Kennedy Institute of Ethics Journal 17 (3):203-226.
Franklin G. Miller & Howard Brody (2007). Clinical Equipoise and the Incoherence of Research Ethics. Journal of Medicine and Philosophy 32 (2):151 – 165.
Added to index2009-01-28
Total downloads7 ( #134,900 of 556,837 )
Recent downloads (6 months)0
How can I increase my downloads?