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Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
Session Chair(s)
Xiang Zhang, PhD
Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence
CSL Behring, United States
Externally controlled clinical trials emerges as a viable alternative to traditional RCTs but come with risks such as confounding and bias. This session will focus on discussing these challenges and how to mitigate them via design and analysis.
Learning Objective : Identify and describe various sources of bias in externally controlled clinical trials, and illustrate their impact on causal effect estimation; Review and assess statistical methods developed to estimate causal treatment effect from externally controlled trials; Discuss regulatory perspectives on the use of external controls for drug development and registration.
Speaker(s)
EMA Perspective
Representative Invited
European Medicines Agency, Netherlands
Industry Perspective
Ran Duan, PhD
Vertex Pharmaceuticals, United States
Director Biometrics
FDA Perspective
Representative Invited
FDA, United States
Industry Perspective
Jingyu (Julia) Luan, PhD
AstraZeneca, United States
Executive Regulatory Science Director, BioPharmaceuticals R&D
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