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DIA/FDA Biostatistics Industry and Regulator Forum


Session 2: Complex Innovative Designs

    Session Chair(s)
      Min  Lin, MD, PhD

      Min Lin, MD, PhD

      • Mathematical Statistician, Division of Biostatistics, CBER
      • FDA, United States
      Amy  Xia, PhD

      Amy Xia, PhD

      • Executive Director, Biostatistics
      • Amgen Inc., United States
    Both the 21st Century Cures Act and the PDUFA VI legislations emphasize on complex innovative designs, which require simulations to understand the design operating characteristics, statistical properties, and operational features. This session will review and discuss the issues related to any complex trial design that we need to simulate the trial to understand its full behavior. Additionally, it will discuss analyses that are complex enough so that we likely need simulation for deeper understanding of the models. Examples of complex analyses include using hierarchical analyses and historical data will be given. A group of speakers and panelists will discuss opportunities and challenges relative to complex innovative designs and analyses in medical product development.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Discuss the role of simulation in complex innovative designs and analyses
    • Discuss case studies in complex innovative designs and analyses
    • Describe challenges and opportunities in complex innovative designs and analyses
    Speaker(s)
      John  Scott, PhD

      Simulations for Clinical Trial Operating Characteristics

      John Scott, PhD

      • Acting Director, Division of Biostatistics, OBE, CBER
      • FDA, United States
      Scott M Berry, PhD

      Complex Clinical Trials: Design and Analysis

      Scott M Berry, PhD

      • President and Senior Statistical Scientist
      • Berry Consultants LLC, United States
      Brian  Hobbs, PhD

      Panelist

      Brian Hobbs, PhD

      • Associate Staff of Quantitative Health Sciences, The Section Head of C
      • The Taussig Cancer Institute at Cleveland Clinic , United States
      Karen Lynn Price, PhD, MA

      Panelist

      Karen Lynn Price, PhD, MA

      • Senior Research Advisor
      • Eli Lilly and Company, United States
      Estelle  Russek-Cohen, PhD

      Panelist

      Estelle Russek-Cohen, PhD

      • Director, Division of Biostatistics, OBE, CBER
      • FDA, United States