Navigating Indirect Comparisons in Clinical Research
This chapter explores the intricacies of performing indirect comparisons using non-randomized data within clinical research. It highlights the challenges of integrating randomized controlled trials with observational studies, focusing on bias management and the significance of rigorous data collection. Furthermore, the discussion emphasizes the role of real-world evidence in enhancing trial design, specifically in terms of understanding patient populations and improving statistical power.
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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
🔗 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.
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.
Join the Conversation: Did you find this episode helpful? Share it with your colleagues and let me know your thoughts! Connect with me on LinkedIn and be part of the discussion.
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