Sentinel Event Methods for Monitoring Unanticipated Adverse Events

摘要

We propose an approach to monitoring unanticipated adverse events in a clinical trial. For a specific type of event, the methods allow the first occurrence, the first few occurrences, or an elevated rate to trigger a formal monitoring plan to identify whether that event occurs more frequently in the treated than in the control arm. The methods can apply either to rare events or to common events not expected to occur at an elevated rate in the treated group. We offer some simple models, emphasizing that, by the very nature of its rarity, a rare event is quite difficult to monitor.