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DIA 2018 Global Annual Meeting

Use of Historical Information in Clinical Trial Design

    Session Chair(s)
      Sara  Jimenez, PhD, MS

      Sara Jimenez, PhD, MS

      • Mathematical Statistician, OB, OTS, CDER
      • FDA, United States
    The use of historical controls in clinical trials may be an alternative method to assess the efficacy of a new drug. Challenges that arise from the use of historical controls, as well as methods for overcoming those challenges, will be discussed.
    Learning Objective : Determine whether the use of a historical control is appropriate for their clinical trial design; Determine how to analyze endpoints and interpret results from clinical trials that use a historical control.
      Edward  Bowen, MBA, MS

      Using Historical Data to Transform Clinical Trials

      Edward Bowen, MBA, MS

      • Head of Data Science and Solutions
      • GlaxoSmithKline, United States
      Andrew  Wilson, PhD, MS

      Converging Lines of Evidence: Using Modern Structural Meta-analysis to Advance Multisite Knowledge Discovery - A Case Study

      Andrew Wilson, PhD, MS

      • Director, Pharmacoepidemiology and Statistics RWDS
      • PAREXEL, United States