Strategic lessons from the clinical event classification process for the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) trial.

Abstract

BACKGROUND Independent adjudication of clinical trial events is traditionally performed by physicians on a clinical event classification (CEC) committee. OBJECTIVES The experience of the centralized CEC group of the APEX-AMI trial is described. This group adjudicated key secondary pre-specified outcome measures of congestive heart failure (CHF) and… (More)
DOI: 10.1016/j.cct.2010.12.013

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