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Risk-Based Monitoring for Master Protocol Study: A Dilemma and Possible Ways to Go
Session Chair(s)
Rachael Cui Song, MBA
Associate Director, Global Project Management
PPD, United States
Master protocol studies include 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 components of a master protocol study and the unique challenges for implementation; Identify the key success factors and challenges to apply risk-based monitoring for a master protocol study.
Speaker(s)
Applying Risk-Based Monitoring to Operationally Complex Studies: Opportunities for Improved Quality and Flexibility
Mary Arnould, BSN, MSN
Astellas, United States
Director, Clinical Science Operations
ICH E6 (R2): A Miracle Pill for Clinical Research
Steve Young, MSC
CluePoints, United States
Chief Scientific Officer