Recurrent Event Endpoints - Some Regulatory Experience
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Heng Li, FDA/CDRH  *Vandana Mukhi, FDA/CDRH  Yunling Xu, Division of Biostatistics, OSB/CDRH/FDA  Yu Zhao, FDA/CDRH 

Keywords: Andersen-Gill, Days Alive Out of Hospital, Poisson

Time to Death has had a key role in medical statistics since reducing mortality is the ultimate objective of many medical therapies. However, time to events other than death are also often of interest. Such events may occur more than once during a patient’s follow-up in a clinical study. In this presentation we will provide the motivation for using endpoints involving recurrent event types of data, discuss possible statistical strategies for their analyses and share some challenges from a regulatory perspective.