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Tuesday, June 26 • 10:30am - 11:45am
#241: Time-to-Event Analysis in Clinical Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-585-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will present statistical methods for analyzing adverse events with a focus on time to occurrence of the first adverse event. Speakers will discuss practical implications of the analysis of AE data in clinical trials and give illustrative examples. The topic of competing risks (e.g., non-event-related death) that preclude the observation of the event of interest will be discussed and two methodologies will be proposed.

Learning Objectives

Discuss current problems and solutions for analysis of time-to-event data; Identify new insights and a novel approach for the analysis of drug safety data with the presence of competing risks; Describe extensions to efficacy endpoints.


Brenda Crowe, PhD


The Challenges of Analyzing Drug Safety Data with Competing Risk Events and Some Thoughts
William Wang, PhD

Academic Perspective
Tim Friede

avatar for Brenda Crowe

Brenda Crowe

Senior Research Advisor, Global Statistical Sciences, Eli Lilly and Company
Brenda Crowe is a Senior Research Advisor at Eli Lilly and Company (Lilly) where she leads a Safety Analytics team. She obtained a PhD in Statistics from the University of Toronto in 1997 and has 20 years of pharmaceutical industry experience.
avatar for Tim Friede

Tim Friede

Professor of Biostatistics, Universitätsmedizin Göttingen
Since 2010 Tim Friede is Professor of Biostatistics at the University Medical Center Göttingen (Germany) where he leads the Department of Medical Statistics. He graduated in mathematics from the Karlsruhe University and obtained a PhD from the Heidelberg University. In 2001 he joined... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →

Tuesday June 26, 2018 10:30am - 11:45am EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session