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DIA 2018 Global Annual Meeting

The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.

Use of Historical Information in Clinical Trial Design

    Session Chair(s)
      Sara  Jimenez, PhD

      Sara Jimenez, PhD

      • 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 Determine whether the use of a historical control is appropriate for their clinical trial design; Discuss how to analyze endpoints and interpret results from clinical trials that use a historical control.
      Edward  Bowen, MA, MBA, MS

      Efforts to Combine Data Across Companies

      Edward Bowen, MA, MBA, MS

      • Lead, Placebo as Standard of Care Workstream
      • TransCelerate BioPharma, United States
      Jessica  Lim, MA

      Using Historical Data to Transform Clinical Trials: Statistical Considerations

      Jessica Lim, MA

      • Director, Clinical Statistics
      • 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