Safety Scientific Working Group

Structure of SWG

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
 

*) Public Private Partnership with US FDA in place

Each workstream includes several task forces (TF), which are deliverable-based and time-bounded.  For details please refer to the individual workstreams.