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Time-to-Event Analysis in Clinical Trials
Session Chair(s)
Brenda Crowe, PhD
Associate Vice President, Statistics
Eli Lilly and Company, United States
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 Objective : 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.
Speaker(s)
The Challenges of Analyzing Drug Safety Data with Competing Risk Events and Some Thoughts
William Wang, PhD
Merck & Co, Inc, United States
President
Academic Perspective
Tim Friede
University Medical Center Goettingen, Germany
Professor of Biostatistics and Chair, Department of Medical Statistics
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