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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
Vice President, Science Policy, Friends of Cancer Research, United States
Toward Greater Use of RWD-Based External Controls in Regulatory Decisions: Design and Methods Considerations
Khaled Sarsour, PhD, MPH
Vice President and Global Head, Evidence Generation and Advanced Analytics, Astellas, United States
Industry Update
Craig White, PhD
Senior Vice President and Managing Director, Outcomes Science, Concertai, United States
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