Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go
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.
ICH E6 (R2): A Miracle Pill for Clinical Research
Stephen Young, MSc
Chief Operations Officer
CluePoints, United States
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