Co-Chairs *)
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Jürgen Kübler (2023-2025), Lothar Tremmel (2024-2026), Tarek Hammad (2025-2027)
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Workstream 1 Interdisciplinary Safety Evaluation
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Workstream 2 Safety Monitoring Statistical Methodology
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Workstream 3 Integration and Bridging the RWE and RCT for Safety Decision Making |
OCT Outreach & Communication Team
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Lothar Tremmel, Barbara Hendrickson, Maria Verdugo Lisa Rodriquez*
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Melvin Munsaka, Michael Fries, Ellen Snyder, tbd*
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Lian Lin, Birol Emir, Haitao Chu, Yong Ma* |
Michelle Zhang |
Taskforce 1 Aggregated Safety Assessment Planning (ASAP)
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Taskforce 1 BR in Multiregional trials |
Taskforce 1 Statistical and design considerations for real world evidence in health decision making
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Scientific Webinar
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Lothar Tremmel, Barbara Hendrickson
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Melvin Munsaka |
Haitao Chu, Ellen Snyder
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Michelle Zhang, James Buchanan, Mengchun Li, Susan Mayo*
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Taskforce 2 Interactive safety graphics (ISG)
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Taskforce 2 Book Add-ons and updates |
Taskforce 2 Design and Analyses of the Pharmacoepi Studies |
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Natalie Andriychuck, James Buchanan, Xiao Ni, Mengchun Li
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Melvin Munsaka |
Lian Lin, Bill Wang |
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Taskforce 3 Benefit Risk Assessment Planning (BRAP)
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Taskforce 3 ML, AI, NLP in drug safety data |
Taskforce 3 Advanced methods and analytics in application to RCT and RWE
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Brian Edwards, James Higginson
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Melvin Munsaka |
Birol Emir, Ed Whalen |
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Taskforce 4 Benefit Risk Assessment Tool Suite (BRATS) |
Taskforce 4 Visual analytic methods, tools |
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Mengchun Li, Brian Waterhouse |
Melvin Munsaka |
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Taskforce 5 Estimand for integrated analyses |
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Katarina Hedman
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Taskforce 6 Causal Inference |
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Wei Wang |
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Taskforce 7 Bayesian Methods |
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Mike Fries
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Taskforce 8 Quantitative methods for safety data in oncology trials |
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Ellen Snyder
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Taskforce 9 Safety monitoring/aggregate reporting in clinical trials - FDA guidance 2021 |
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Rima Izem
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