Recurrent Event Endpoints - Some Regulatory Experience
View Presentation 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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC