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Using Real-World Data in Single-Arm Trials: When It’s Done, Why It’s Done, How It’s Done
Session Chair(s)
David Thompson, PHD
Founder and Principal Consultant
Rubidoux Research LLC, United States
As real-world data increasingly provide synthetic controls in single-arm drug registration studies, terminology and insights have evolved. The structured, multistep assessment process described addresses why, when, and where to use new approaches.
Learning Objective : Describe fundamentals of synthetic control arms and real-world data integration into clinical trials; Discuss relevant key terminology; Evaluate feasibility of using an external control arm in a clinical trial; Identify how to weigh pros and cons of historical versus concurrent control arm data; Identify potential external sources for control populations.
Speaker(s)
Application of Real-World Evidence to Support Breakthrough Drug Development
Mark Stewart, PHD
Friends of Cancer Research, United States
Vice President, Science Policy
Toward Greater Use of RWD-Based External Controls in Regulatory Decisions: Design and Methods Considerations
Khaled Sarsour, PHD, MPH
Genentech, A Member of the Roche Group, United States
Global Head, RWD Hematology-Oncology
Industry Update
Craig White, PHD
Concertai, United States
Senior Vice President and Managing Director, Outcomes Science