Ying nan Wu
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Emulating the LEADER trial in China: a regulatory science case study on non-interventional research
Abstract Introduction: Integrating real-world evidence (RWE) into regulatory decision-making requires validation against pivotal randomized controlled trials for the same estimand. We emulated the LEADER trial using Chinese claims data to evaluate liraglutide’s cardiovascular safety, assessing RWE-RCT concordance and examining the methodological adaptations and operational challenges encountered when emulating RCTs with claims data.
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