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Bias and Methodological Challenges in External Control Arms Addressing Time-Related Bias, Endpoint Alignment, Unmeasured Confounding
Session Chair(s)
Ju-Young Shin, 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)
Choosing an Index Date for Untreated Patients in External Comparator Studies
Ju Hwan Kim, PHARMD, PHD
Sungkyunkwan University, Korea, Republic of
Research Professor
Quantifying and mitigating measurement bias in real-world endpoints when constructing external control arms
Benjamin Ackerman, PHD
Johnson & Johnson, 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
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