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