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DIA 2018 Global Annual Meeting


Time-to-Event Analysis in Clinical Trials

    Session Chair(s)
      Brenda  Crowe, PhD

      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
    Speaker(s)
      Qi  Zhu, PhD

      The Challenges of Analyzing Drug Safety Data with Competing Risk Events and Some Thoughts

      Qi Zhu, PhD

      • Biostatistician
      • Novartis Pharma Co., Ltd., China
      Tim  Friede, PhD

      To be determined

      Tim Friede, PhD

      • Professor of Biostatistics and Chair, Department of Medical Statistics
      • University Medical Center Goettingen, Germany