Document Detail


Clinical endpoint adjudication in a contemporary all-comers coronary stent investigation: Methodology and external validation.
MedLine Citation:
PMID:  22975439     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND: Globalisation in coronary stent research calls for harmonization of clinical endpoint definitions and event adjudication. Little has been published about the various processes used for event adjudication or their impact on outcome reporting. METHODS AND RESULTS: We performed a validation of the clinical event committee (CEC) adjudication process on 100 suspected events in the RESOLUTE All-comers trial (Resolute-AC). Two experienced Clinical Research Organisations (CRO) that had already extensive internal validation processes in place, participated in the study. After initial adjudication by the primary-CEC, events were cross-adjudicated by an external-CEC using the same definitions. Major discrepancies affecting the primary end point of target-lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI), or clinically-indicated target-lesion revascularization (CI-TLR), were analysed by an independent oversight committee who provided recommendations for harmonization. Discordant adjudications were reconsidered by the primary CEC. Subsequently, the RAC database was interrogated for cases that based on these recommendations merited re-adjudication and these cases were also re-adjudicated by the primary CEC. Final discrepancies in adjudication of individual components of TLF occurred in 7 out of 100 events in 5 patients. Discrepancies for the (hierarchical) primary endpoint occurred in 5 events (2 cardiac deaths and 3 TV-MI). After application of harmonization recommendations to the overall RAC population (n=2292), the primary CEC adjudicated 3 additional clinical- TLRs and considered 1 TV-MI as no event. CONCLUSIONS: A harmonization process provided a high level of concordance for event adjudication and improved accuracy for final event reporting. These findings suggest it is feasible to pool clinical event outcome data across clinical trials even when different CECs are responsible for event adjudication.
Authors:
Pascal Vranckx; Eugene Mc Fadden; Donald E Cutlip; Roxana Mehran; Michael Swart; P P Kint; Felix Zijlstra; Sigmund Silber; Stephan Windecker; P W J C Serruys
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-10
Journal Detail:
Title:  Contemporary clinical trials     Volume:  -     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012 Elsevier Inc. All rights reserved.
Affiliation:
Cardialysis, Clinical Research Management & Core Laboratories, Rotterdam, The Netherlands. Electronic address: pascal.vranckx@jessazh.be.
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