1) Review recent advances in statistical approaches for supplementing randomized trials with RWD, grounded in the causal inference roadmap, to accelerate and expand the generation of robust evidence to support regulatory decision-making.
2) Produce a joint white paper discussing current statistical methods, best practices, and remaining methodological challenges to the integration of RWD and randomized data to support regulatory decisions.
3) Build on prior work, including earlier workshops, to expand the ongoing dialogue between stakeholders -- emphasizing the regulatory and statistical challenges associated with innovative approaches to combining data sources to overcome limitations in both trial and RWD.