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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