The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Time-to-Event Analysis in Clinical Trials
Brenda Crowe, PhD
Senior Research Advisor, Global Statistical Sciences
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 : 1. This presentation provides a new insight of analyzing drug safety data with the presence of competing risk events using a novel approach
2. It can be readily extended to the analysis of efficacy endpoints when the occurrences of both events of interest and competing risks are rare, with more relaxed assumptions
The Challenges of Analyzing Drug Safety Data with Competing Risk Events and Some Thoughts