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DIA 2018 Global Annual Meeting


Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go

    Session Chair(s)
      Rachael Cui Song, MBA

      Rachael Cui Song, MBA

      • Senior Project Manager - Hematology/Oncology
      • PPD, United States
    Master protocol studies includes basket study, umbrella study, platform study, and etc. It provides possibilities to shorten R&D timelines, reduce R&D costs, and improve probability of success if designed and implemented properly. One of the primary key success factors for a master protocol study is the “real-time” collection and analysis of data with high quality to enable “real-time” decision making. Risk-based monitoring (RBM) provides an opportunity to address the needs of data currency and data quality by integrating data-driven risk assessment, statistical monitoring, and data analytics. However there are certain challenges to implement RBM for a master protocol study, due to the more complex design and dynamic nature. The session will discuss the opportunity, challenges, and potential ways to apply RBM for a master protocol study.
    Learning Objective : Describe what is a master protocol study and the unique challenges to implement a master protocol study; Identify the needs and challenges to apply risk-based monitoring for a master protocol study; Assess the possibility and understand key success factors to apply risk-based monitoring for a master protocol study.
    Speaker(s)
      Stephen  Young, MSc

      ICH E6 (R2): A Miracle Pill for Clinical Research

      Stephen Young, MSc

      • Chief Operations Officer
      • CluePoints, United States
      Mary  Arnould, BSN, MSN

      Apply Risk-Based Approach to Address Data Currency and Quality Issues in Master Protocol Studies

      Mary Arnould, BSN, MSN

      • Director, Clinical Science Operations
      • Astellas Pharma Global Development, Inc., United States