Delays of Event Adjudication in the TRITON Trial

作者：Serebruany Victor L^*

来源：Cardiology, 2010, 115(3): 217-220.

DOI：10.1159/000296016

• Prasugrel
• Clopidogrel
• Clinical trials
• Event adjudication
• Antiplatelet therapy

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.

• 出版日期2010