Name: Externally Controlled Trials in Clinical Development: Challenges and Mitigation Strategies
Start: 2025-06-17T16:00:00-0400
End: 2025-06-17T17:00:00-0400

Tuesday June 17, 2025 4:00pm - 5:00pm EDT

TBD

Component Type: Session
Level: Intermediate

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 Objectives

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.

Chair

Xiang Zhang, PhD

Speakers

Xiang Zhang

Head of Medical Affairs and HTA Statistics/Co-lead FORExcellence, CSL Behring, United States

Xiang Zhang is the Head of Medical Affairs and HTA Statistics and a co-lead of the Forum for Observational Research Excellence (FORExcellence) at CSL. He leads a team of statisticians, epidemiologists, and RWE scientists that promotes best practices in RWE generation at CSL. His team... Read More →

Tuesday June 17, 2025 4:00pm - 5:00pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA

11: Statistics-Data Science, Session

Level Intermediate
Level Intermediate
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Tags Session

DIA 2025 Global Annual Meeting

Xiang Zhang

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