All Times EDT
Keywords: propensity score, comparative effectiveness, validity
We will introduce a case study of utilizing real world evidence as part of the evidence package for a new drug indication approval in China. The presentation outline includes: 1) Identifying fit-for-purpose real-world data (RWD) source 2) Standard pharmacoepidemiological approaches to address measured and unmeasured confounding in RWE study 3) Reproducibility of study results and other challenges 4) Best practices for close collaboration between statisticians and epidemiologists, and 5) Interactions between sponsor and regulatory agency.