Procon clinical debate It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility 英文参考文献.docVIP

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Procon clinical debate It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility 英文参考文献.doc

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Procon clinical debate It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility 英文参考文献

Critical Care February 2005 Vol 9 No 1 Schoenfeld and Meade Review Pro/con clinical debate: It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility David A Schoenfeld1 and Maureen O Meade2 1Professor of Medicine, Harvard Medical School, Professor, Department of Biostatistics, Harvard School of Public Health, Massachusetts General Hospital, Boston, Massachusetts, USA 2Associate Professor, Department of Medicine and Department of Clinical Epidemiology Biostatistics, McMaster University, Hamilton, Ontario, Canada Corresponding author: David A Schoenfeld, dschoenfeld@ Published online: 9 December 2004 Critical Care 2005, 9:34-36 (DOI 10.1186/cc3013) This article is online at /content/9/1/34 ? 2004 BioMed Central Ltd Abstract A few recent, large, well-publicized trials in critical care medicine have been stopped for futility. In the critical care setting, stopping for futility means that independent review committees have elected to stop the trial early — based on predetermined rules — since the likelihood of finding a treatment effect is low. For bedside clinicians the idea of futility in a clinical trial can be confusing. In the present article, two experts in the conduct of clinical trials debate the role of futility-stopping rules. Keywords clinical research, futility, interim analysis, randomized controlled trials, stopping rules The scenario You are a clinician in an intensive care unit and you have were very relevant clinical questions that would impact on your treatment decisions. Your concern is based on the fact that you are uncertain whether clinical trials should ever be stopped for futility. recently heard that some very large trials have been stopped at interim analysis for futility. Although you have not yet seen the results, this cessation concerns you because you were anxiously awaiting the results of these trials since you felt they Pro: