Case study of semaglutide and cardiovascular outcomes: An application of the C ausal Roadmap to a hybrid design for augmenting an RCT control arm with real-world data.

helps investigators to minimize potential bias in studies using RWD and to quantify tradeoffs between study designs. The simulation results help to interpret the level of evidence provided by the real data analysis in support of the superiority of oral semaglutide versus standard-of-care for cardiovascular risk reduction.