The RWD/RWE Informed Clinical Trial Work Stream reviewed the state of the science of how RWD/RWE can inform better clinical trial design. The Work Stream has performed a gap analysis and identified a research agenda with prioritized items. In this presentation, the speaker will first highlight the results of their literature review, followed by a summary of gap analysis. Next, the Work Stream will discuss a research agenda outline. In conclusion, the Work Stream will solicit feedbacks from the statistics community.