Integrating Real-World Evidence in Clinical Assessments

Interview with Katrin Kupas

What You’ll Learn in This Episode:

✔ What the JCA is and why it changes how we plan evidence generation

✔ When and how RWE can help answer comparator questions in HTA

✔ The risks of non-randomized comparisons—and how to mitigate them

✔ Why we need an integrated evidence plan early in development

✔ How tools like ROBINS-I and quantitative bias analysis can improve credibility

Why You Should Listen:

If you’re a statistician, medical affairs lead, or part of an HEOR or market access team, this episode will help you:

✔ Develop a stronger evidence generation plan across the drug lifecycle

✔ Understand how real world evidence can support JCA submissions

✔ Learn when RCTs aren’t enough—and how RWE can fill the gap

✔ Gain practical advice for designing indirect treatment comparisons

✔ Improve your bias assessment strategies with tools like ROBINS-I

Resources & Links:

🔗 ROBINS-I Tool – for evaluating bias in non-randomized studies

🔗 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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