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Session 3: Methodological Insights on External Controls and Sensitivity Analyses
Session Chair(s)
John Concato, MD, MPH, MS
Associate Director for Real-World Evidence Analytics, OMP, CDER
FDA, United States
This session will highlight specific methodological issues relevant to real-world evidence. The first presentation will discuss results obtained when applying different methods to analyze data in externally controlled trials; the second presentation will discuss how external control arm data can help interpret results from single-arm trials; the third presentation will discuss a structured framework for sensitivity analyses to assess unmeasured confounding. A panel discussion will follow.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe various statistical approaches for analyzing data in externally controlled trials
- Identify how external control arm data can be used to inform early decisions in drug development programs
- Recognize statistical methods used in sensitivity analyses to assess unmeasured confounding
Speaker(s)
To Pursue or Not? How External Controls Were Used to Decide the Course of Two New Recurrent Glioblastoma Treatments
Lisa Ensign, PhD, MSc
Medidata, a Dassault Systemes Company, United States
VP, Statistics and Regulatory Science Innovation
Deriving External Controls Arms From RWD: G-Computation and Digital Twins Applied to a Small Single Arm Phase 1 Trial
David Paulucci, MSc
BMS, United States
Director, Data Science
Evaluating the Robustness of Real-World Evidence through Quantitative Sensitivity Analysis for Unmeasured Confounding
Mingyang Shan, PhD
Eli Lilly and Company, United States
Senior Advisor
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