Real World Evidence Scientific Working Group

Welcome to the home page of the Real-World Evidence Scientific Working Group (RWE SWG).

Our goals are to:

  • Advance the understanding of the RWE research in a precompetitive space
  • Engage regulators on providing guidance and/or guiding principles on RWE research
  • Facilitate utilization and implementation of RWD and RWE in clinical research and medical product life cycle
  • Where appropriate, develop statistical methodologies for evidence synthesis and to advance analysis approaches
  • Educate the broader statistical community to understand and contribute to this important area
  • Increase statisticians’ leadership roles in cross-functional collaboration
  • Communicate statistical perspectives to larger clinical trial community

The RWE SWG was co-founded by Weili He and Martin Ho in early 2018.

Expectations for members:

  • Have experience in RWD and RWE research
  • Have strong technical skills and strategic thinking
  • Have time to take part at working group meetings and complete necessary tasks
  • Contribute actively

For more information, please contact Jie Chen at jiechen0713@gmail.com, Yixin Fang at Yixin.fang@abbvie.com, and Hana Lee at hana.lee@fda.hhs.gov.

Note: The phase III project of the RWE has closed the recruitment of new members.


Our charter can be found here.