Introduction to the Analysis of Recurrent Events in Clinical Trials

Abstract

In clinical trials where the aim lies in observing the occurrence of new events during the follow-up period, the main focus is usually on the time elapsed until the initial event occurs. If this initial event is non-fatal, adopting this approach means that information from subsequent incidents will be lost. However, when capturing the effect of treatment on the total burden of disease is of interest, it is recommended to include recurrent events into analysis. Recurrent events are defined as endpoints that occur after the initial event, as determined by researchers. Examples include readmissions, undergoing specific procedures, clinical worsening, and death during the follow-up period.