Real-World Evidence vs. Randomized Trials: Can We Emulate Accuracy?
Keynote by Prof. Sebastian Schneeweiss | The Effective Statistician Conference 2024
The Effective Statistician - in association with PSI
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Show Notes
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
Resources & Links:
🔗 JAMA 2023 RCT DUPLICATE Publication
🔗 RCT DUPLICATE protocols and SAPs on ClinicalTrials.gov
🔗 FDA Framework for Real-World Evidence
🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.
🔗 Medical Data Leaders Community – Join my network of statisticians and data leaders to enhance your influencing skills.
🔗 My New Book: How to Be an Effective Statistician - Volume 1 – It’s packed with insights to help statisticians, data scientists, and quantitative professionals excel as leaders, collaborators, and change-makers in healthcare and medicine.
🔗 PSI (Statistical Community in Healthcare) – Access webinars, training, and networking opportunities.
If you’re working on evidence generation plans or preparing for joint clinical advice, this episode is packed with insights you don’t want to miss.
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