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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)
Recurrent Event Data Endpoints in Cardiovascular Outcome Trials: What is the Estimand of Interest?
Guenther Mueller-Velten, MS
Novartis Pharma AG, Switzerland
Senior Global Group Head Biometrics & Statistical Sciences
New Approaches to Capturing Disease Burden in Cardiovascular Studies
Brian Claggett, PhD, MA, MS
Harvard Medical School, United States
Instructor
Joining the Speakers
Q&A Panel Discussion
United States
Discussant
Norman Stockbridge, MD, PhD
FDA, United States
Director, Division of Cardiology and Nephrology, OND, CDER
Panelists
H. M. James Hung, PhD
FDA, United States
Director, Division of Biometrics I, Office of Biostatistics, OTS, CDER
Bruce Binkowitz, PhD, MSc
Arcutis Biotherapeutics, Inc., United States
Vice President, Biometrics