Clinical event committees in coronary stent trials: insights and recommendations based on experience in an unselected study population.

AIMS

To introduce the interested reader to the concepts of the Clinical Event Committee (CEC) work process with a focus on the adjudication of major endpoints in contemporary coronary stent trials.

METHODS AND RESULTS

Endpoint adjudication by independent Clinical Events Committees (CEC) is critical to ensure the generation and recording of quality data in clinical outcome trials. CEC adjudication provides a standard, systematic and unbiased assessment of endpoints. For trials with relatively long-term clinical endpoints that span geographic regions and include diverse clinical presentations and practice patterns, this poses specific challenges. The recently published RESOLUTE All Comer coronary stent trial is used to illustrate some aspects of the CEC process.

CONCLUSIONS

Understanding the CEC review process is important to guide the design of future trials and allow meaningful comparisons of event rates among trials.