Viewpoint: Central adjudication of myocardial infarction in outcome-driven clinical trials - Common patterns in TRITON, RECORD, and PLATO?

Victor L. Serebruany, Dan Atar

Research output: Contribution to journalArticle

Abstract

Central adjudication in randomised controlled outcome-driven trials represents a traditional approach to maintain data integrity by applying uniformed rules for assessment of clinical events. It was the purpose of this investigation to determine the patterns of myocardial infarction (Ml) adjudication in the TRITON, RECORD, and PLATO trials. We were matching centrally-adjudicated Mi's (CAMI's) from the official trial publication with the site-reported Ml (SRMI's) count from the Food and Drug Administration's secondary analyses for the investigational compounds prasugrel (TRITON), rosiglitazone (RECORD), and ticagrelor (PLATO). CAMI numbers showed a remarkable discrepancy to SRMI's by more than a doubling of the difference: from 72 to 145 events in TRITON favoring prasugrel (from a hazard ratio [HR]=0.76, p=0.08; to a HR=0.76, p

Original languageEnglish (US)
Pages (from-to)412-414
Number of pages3
JournalThrombosis and Haemostasis
Volume108
Issue number3
DOIs
StatePublished - Sep 2012

Keywords

  • Clinical trials
  • Event adjudication
  • Myocardial infarction
  • Prasugrel
  • Rosiglitazone
  • Ticagrelor

ASJC Scopus subject areas

  • Hematology

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