All Times EDT
Keywords: workstream, Real World Evidence
The ASA Biopharmaceutical Section Real-World Evidence Scientific Working Group has completed its review of the biostatistics landscape related to the use of real-world evidence for regulatory purposes. One of the two workstreams of the working group focused on statistical issues related to label expansion. This presentation will discuss several findings from this workstream and present some promising areas of research for statisticians. In particular, this presentation will address regulatory, data source, study variables, and estimand issues. After providing a review of these topics, the presentation will focus on estimands for RWE, one of the topics the working group will continue to explore for RWE applications. The companion presentations in this session will provide the complementary statistical considerations for real-word evidence to provide the full landscape.