Online Program

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All Times EDT

Thursday, September 24
Thu, Sep 24, 12:00 PM - 1:15 PM
Virtual
Roundtables

TL12-Analyzing Recurrent Events in Cardiovascular Outcome Trials (301100)

*Samvel Gasparyan, AstraZeneca R&D 

Keywords: recurrent events, time-to-event analysis, estimand, terminal events, regulatory

This discussion will address statistical, clinical and regulatory issues in analyzing recurrent events in cardiovascular outcome trials. Repeated events, such as heart failure hospitalizations in a heart failure population, or myocardial infarctions in subjects with established cardiovascular disease capture more of the burden of the underlying disease. We will try to address questions of clinical interpretability of the treatment effect measured by a recurrent event model and associated regulatory questions of labeling. Designing new studies based on the recurrent event analysis will be scrutinized, especially in comparison to considering only time-to-event analysis based only on the first event. Model selection problems in the setting of recurrent event analysis will be discussed, attention will be paid to analyzing recurrent events in the presence of terminal events, such as death. The goal of the discussion is to consider all aspects related to including recurrent event analysis in the testing hierarchy of a cardiovascular outcome trial or designing studies based on such an endpoint.