This chapter examines the comparison between real-world evidence and randomized clinical trials, particularly in the contexts of stroke prevention and hypertension management. It highlights specific trials, discusses the methodological challenges of emulating RCTs, and emphasizes the importance of data quality and transparency. The chapter also addresses how real-world findings can inform regulatory decision-making and improve patient care while navigating the complexities of treatment adherence and trial design.
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Keynote by Prof. Sebastian Schneeweiss | The Effective Statistician Conference 2024
What You’ll Learn:
✔ The motivation behind emulating randomized trials using real-world data
✔ How claims and EHR data can support regulatory-grade evidence
✔ What makes a trial emulation good vs. suboptimal
✔ The role of adherence, measurement limitations, and data quality
✔ Use cases where RWE could expand indications or replace costly trials
✔ Key takeaways from the RCT DUPLICATE project and the “Benchmark-Calibrate-Extrapolate” strategy
Recommended For:
✔ Biostatisticians and epidemiologists
✔ Health tech innovators and data scientists
✔ Regulatory affairs and clinical development professionals
✔ Anyone involved in real-world data, RWE, or comparative effectiveness research
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