Role of clinical evaluation committees in sepsis trials from valid cohort assessment to subgroup analysis 英文参考文献.docVIP

Available online /content/13/2/124 Commentary Open Access Vol 13 No 2 Role of clinical evaluation committees in sepsis trials: from valid cohort assessment to subgroup analysis Jean-Fran?ois Dhainaut Université Paris Descartes, Service de réanimation Médicale, H?pital Cochin, 75014 Paris, France Corresponding author: Jean-Fran?ois Dhainaut, dhainaut@aeres-evaluation.fr Published: 18 Mar 2009 Critical Care 2009, 13:124 (doi:10.1186/cc7686) This article is online at: /content/13/2/124 ? 2009 BioMed Central Ltd See related research by Laterre et al., /content/13/2/R36 Abstract In this issue of Critical Care, the study from Laterre and colleagues offers suggestions for the role of clinical evaluation committees (CECs) in future sepsis trials. Despite encouraging preliminary results, all randomized controlled trials (RCTs) devoted to potential compounds in severe sepsis have failed to show survival benefit. One of the reasons might be related to in sepsis. The role of CECs has shifted to become a more integral part of the detailed analysis of drug safety and efficacy in large databases, and to identify subgroups of patients in which a therapy might be less or more effective and/or safe. As an example, the retrospective analysis by Laterre and colleagues community-acquired pneumonia (sCAP) within a large, failed RCT (on recombinant tissue factor pathway inhibitor (rTFPI)). However, the results should be interpreted with great caution, and should be viewed as exploratory and a hypothesis-generating activity. This question of potential benefit of rTFPI in patients with sCAP will be definitively answered by the results of the recently completed RCP. focuses on patients with severe RCT-related factors that inevitably occur within a heterogeneous septic patient population. A patient population free from confounding events would seem to provide the most suitable platform upon which to judge therapeutic