Leader Information
| Name | ||
| Mani Lakshminarayanan | wermgrfans@gmail.com | |
| Xiang Zhang | Xiang.Zhang@cslbehring.com |
SubTeam Overview
The inclusion of RWE/D to enhance regulatory decision making has been advocated by FDA in recent years starting with the 21st Century Cures Act, PDUFA VI, and recently 2019 FDA’s strategic framework. This subteam goals are to leverage Bayesian applications of RWE for regulatory decision making including reproducible research to generate credible and reliable RWE and use of RWE in confirmatory trials and clinical planning.
Ongoing Projects
- TBD