The State of Real-World Evidence PolicyRegister
Contact InformationLuke Durocher
MaterialsFinal Agenda RWE Collaborative Convening_10May22.pdf
Speaker Bios_RWE Convening.pdf
Duke-Margolis Comment Letter to FDA on EHRs and Claims Data.pdf
Duke-Margolis Comment Letter to FDA on Registries.pdf
Duke-Margolis Comment Letter to FDA on Data Standards.pdf
Duke-Margolis Comment Letter to FDA on Study Considerations.pdf
State of RWE Convening Slide Deck.pdf
Convened by the Duke-Margolis Real-World Evidence Collaborative, this public conference will provide stakeholders a venue for reviewing progress to-date on strategic real-world data (RWD) and real-world evidence (RWE) policy development activities and on promising future applications of these data and evidence. Discussions will cover shared themes across multiple stakeholders' public comments on recent FDA draft guidance for RWD and RWE - highlighting areas of alignment as well as opportunities for RWE moving forward. Additionally, the event will consider recent work by the Duke-Margolis RWE Collaborative on addressing shared evidentiary needs among regulators and payers and implementing point of care trials using RWE.
The event will conclude with forward looking discussions on key actions and next steps to advance the regulatory use of RWE, highlighting how this could be accomplished within the context of a national data infrastructure that could account for evidentiary needs among broad groups of stakeholders. The discussion will also consider ongoing Congressional developments around RWD and RWE within these contexts.
Released May 11, 2022