Báo cáo y học: "Pro/con clinical debate: It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học Critical Care cung cấp cho các bạn kiến thức về ngành y đề tài: Pro/con clinical debate: It is acceptable to stop large multicentre randomized controlled trials at interim analysis for futility. | 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 1 Professor 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 This article is online at http content 9 1 34 2004 BioMed Central Ltd Critical Care 2005 9 34-36 DOI cc3013 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 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 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. Pro Futility stopping can speed up the development of effective treatments

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