| Early stopping of clinical trials: charting the ethical terrain. | |
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MedLine Citation:
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PMID: 21598846 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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The decision to terminate a clinical trial earlier than planned is often described as ethically problematic, but it is rarely systematically analyzed as an ethical issue in its own right. This paper provides an overview of the main ethical considerations at stake in such decisions and of the main tensions between these considerations. Arguments about informed consent and the impact of early stopping on research and society are explored. We devote particular attention to a familiar conflict that arises with special urgency when early data suggest that the experimental treatment is superior. Should the trial be stopped so that participants in the control group will not be allocated a seemingly inferior treatment, or should it continue in pursuit of evidence conclusive enough to improve the care of future patients? We scrutinize three ways to address this problem. Rather than dissolving the tension, they represent different trade-offs between the respective welfare interests of subjects and future patients. |
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Authors:
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Erik Malmqvist; Niklas Juth; Niels Lynöe; Gert Helgesson |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Kennedy Institute of Ethics journal Volume: 21 ISSN: 1054-6863 ISO Abbreviation: Kennedy Inst Ethics J Publication Date: 2011 Mar |
Date Detail:
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Created Date: 2011-05-23 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9109135 Medline TA: Kennedy Inst Ethics J Country: United States |
Other Details:
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Languages: eng Pagination: 51-78 Citation Subset: E; IM |
Affiliation:
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Centre for Research on Meaning, Ethics and Society, Université Paris Descartes, France. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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