Document Detail


Delays of event adjudication in the TRITON trial.
MedLine Citation:
PMID:  20234133     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Central adjudication of clinical events in randomized controlled trials represents an attractive but still controversial approach since the adjudicated data usually match well with the investigator-reported event rates but increase affiliated costs. PURPOSE: The aim was to assess the timing of clinical event adjudication in the TRITON trial. METHODS: A review of the FDA action package for prasugrel was conducted. RESULTS: Adjudications for deaths and strokes were distributed evenly throughout the study period. Bleeding event adjudications were performed predominantly in the later stages of the study. Adjudications for myocardial infarction and especially stent thrombosis were significantly delayed. CONCLUSIONS: Among all clinical events, only deaths and strokes in TRITON were adjudicated without delays. Late adjudication of myocardial infarction and stent thrombosis are uncommon but at least can be explained by lack or change of event definitions. However, the delays with adjudications of revascularization procedures and especially timely recording of bleeding complications lack reasonable explanation. The regulatory authorities should consider independent audits when there is a major disagreement between centrally adjudicated and site-reported events influencing the results of a major clinical trial.
Authors:
Victor L Serebruany
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Publication Detail:
Type:  Comparative Study; Editorial     Date:  2010-03-16
Journal Detail:
Title:  Cardiology     Volume:  115     ISSN:  1421-9751     ISO Abbreviation:  Cardiology     Publication Date:  2010  
Date Detail:
Created Date:  2010-04-08     Completed Date:  2010-07-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  1266406     Medline TA:  Cardiology     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  217-20     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Acute Coronary Syndrome / drug therapy*,  mortality*
Angioplasty, Transluminal, Percutaneous Coronary / mortality
Cerebral Infarction / mortality,  prevention & control
Coronary Restenosis / mortality,  prevention & control
Data Collection / statistics & numerical data*
Disease-Free Survival
Hemorrhage / chemically induced,  mortality
Myocardial Infarction / mortality,  prevention & control
Observer Variation
Piperazines / adverse effects,  therapeutic use*
Platelet Aggregation Inhibitors / adverse effects,  therapeutic use*
Randomized Controlled Trials as Topic / statistics & numerical data*
Reproducibility of Results
Research Design / statistics & numerical data*
Stents
Thiophenes / adverse effects,  therapeutic use*
Ticlopidine / adverse effects,  analogs & derivatives*,  therapeutic use
Treatment Outcome
United States
United States Food and Drug Administration
Chemical
Reg. No./Substance:
0/Piperazines; 0/Platelet Aggregation Inhibitors; 0/Thiophenes; 0/prasugrel; 55142-85-3/Ticlopidine; 90055-48-4/clopidogrel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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