Document Detail


Clinical event committees in coronary stent trials: insights and recommendations based on experience in an unselected study population.
MedLine Citation:
PMID:  22829511     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Aims: To introduce the interested reader to the concepts of the Clinical Event Committee (CEC) work process with a focus on the adjudication of major endpoints in contemporary coronary stent trials. Methods and results: Endpoint adjudication by independent Clinical Events Committees (CEC) is critical to ensure the generation and recording of quality data in clinical outcome trials. CEC adjudication provides a standard, systematic and unbiased assessment of endpoints. For trials with relatively long-term clinical endpoints that span geographic regions and include diverse clinical presentations and practice patterns, this poses specific challenges. The recently published RESOLUTE All Comer coronary stent trial is used to illustrate some aspects of the CEC process. Conclusions: Understanding the CEC review process is important to guide the design of future trials and allow meaningful comparisons of event rates among trials.
Authors:
Pascal Vranckx; Eugene McFadden; Roxana Mehran; Donald E Cutlip
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology     Volume:  8     ISSN:  1969-6213     ISO Abbreviation:  EuroIntervention     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-25     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101251040     Medline TA:  EuroIntervention     Country:  France    
Other Details:
Languages:  eng     Pagination:  368-74     Citation Subset:  IM    
Affiliation:
Clinical Research Management & Core Laboratories, Cardialysis, Rotterdam, The Netherlands.
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