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Bias and Methodological Challenges in External Control Arms: Time-Related Bias, Endpoint Alignment, Unmeasured Confounding
Session Chair(s)
Ju-Young Shin, PHARMD, PHD
Professor
School of Pharmacy, Sungkyunkwan University, Korea, Republic of
This session highlights methodological challenges in External Control Arms (ECAs) using Real-World Data (RWD). Speakers will address time-related biases, endpoint alignment challenges between RWD and trial standards, and methodological strategies to address unmeasured confounding.
Learning Objective : Discuss exposure and time-related issues in ECA construction, including defining time-zero and avoiding immortal time bias; Describe endpoint alignment challenges between RWD and trial standards, and outline methods to address measurement error and bias; Evaluate approaches for handling missing data and unmeasured confounding, and explain new insights on defining index dates in EC studies.
Speaker(s)
Quantifying and mitigating measurement bias in real-world endpoints when constructing external control arms
Benjamin Ackerman, PHD
Johnson & Johnson Innovative Medicine, United States
Principal Scientist, Biostatistics
Choosing an Index Date for Untreated Patients in External Comparator Studies
Gerd Rippin, PHD
IQVIA, Germany
Senior Director, Biostatistics, Real-World Solutions
Panelist
Ju Hwan Kim, PHARMD, PHD
Sungkyunkwan University, Korea, Republic of
Postdoctoral Research Fellow
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