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Session 4: Data Analysis of Recurrent Events
Session Chair(s)
Mouna Akacha, PHD
Group Head of Statistical Methodology, Novartis Pharma AG, Switzerland
Peiling Yang, PHD
Supervisory Mathematical Statistician, FDA, United States
In many chronic disease trials, treatment effects have been assessed through time-to-event endpoints; e.g. time to death or hospitalization in chronic heart failure trials or time to tumor occurrence in cancer trials. Traditionally, these time-to-event endpoints have been analyzed using a time-to-first-event analysis approach. A recurrent event approach, in which the first as well as subsequent events are included, would more accurately reflect the true burden of the illness on the patient. In this session we will discuss the opportunities and challenges in the use of recurrent event endpoints from a statistical, regulatory and clinical perspective. The focus will lie on cardiovascular outcome trials.
Speaker(s)
Guenther Mueller-Velten, MS
Senior Global Group Head Biometrics & Statistical Sciences, Novartis Pharma AG, Switzerland
Recurrent Event Data Endpoints in Cardiovascular Outcome Trials: What is the Estimand of Interest?
Brian Claggett, PHD, MA, MS
Instructor, Harvard Medical School, United States
New Approaches to Capturing Disease Burden in Cardiovascular Studies
Q&A Panel Discussion
, United States
Joining the Speakers
Norman Stockbridge, MD, PHD
Director, Division of Cardiology and Nephrology, OND, CDER, FDA, United States
Discussant
H. M. James Hung, PHD
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER, FDA, United States
Panelists
Bruce Binkowitz, PHD, MSC
Vice President, Biometrics, Arcutis Biotherapeutics, Inc., United States
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