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Novel and Innovative Clinical Trial Designs: From Adaptive/Seamless Designs to the Trial of the Future

    Session Chair(s)
      Mireille  Muller, DrSc, PhD, MSc

      Mireille Muller, DrSc, PhD, MSc

      • Regulatory Policy Director
      • Novartis Pharma AG, Switzerland
    Multiple trial design options are required to increase efficiency in clinical trial conduct in increasingly complex conditions and smaller populations while maintaining scientific value and data quality to meet the wants of all stakeholders.
    Learning Objective : i) identify and discuss the problems, also ethical and economical, related to phase II planning; ii) evaluate if the techniques adopted for planning phase II are correct, in order to collect enough information to plan the subsequent, eventual, phase III; iii) influence the decisions about phase II planning.
      Michael  Krams, MD

      Platform Trials

      Michael Krams, MD

      • Vice President, Global Head of Quantitative Sciences
      • Janssen R&D, Johnson & Johnson, United States
      Sacha  Wissink, PhD

      Regulatory and HTA Challenges with Innovative Clinical Trials

      Sacha Wissink, PhD

      • Exec. Director Regulatory Affairs EMEA
      • MSD, Netherlands
      Benjamin  Hofner, PhD

      Regulator’s Perspective: Master Protocols – Risks and Benefits

      Benjamin Hofner, PhD

      • Biostatistician
      • Paul-Erhlich-Institut, Germany
      Daniele  De Martini, PhD

      Empowering Phase II Clinical Trials To Reduce Phase III Failures

      Daniele De Martini, PhD

      • Associate Professor
      • Milano-Bicocca University, Italy