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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 3: Methodological Insights on External Controls and Sensitivity Analyses

Session Chair(s)

John  Concato, MD, MPH, MS

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


Lisa  Ensign, PhD, MSc

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, Data Science

David  Paulucci, MSc

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

Mingyang  Shan, PhD

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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