אודות פרק זה
A Conversation with Gorana Capkun
Why You Should Listen
- Understand integrated evidence planning and how it connects evidence generation across functions, stakeholders, and geographies.
- Look beyond regulatory approval to consider what payers, physicians, and patients need from the evidence.
- Strengthen your contribution as a statistician by asking questions that clarify endpoints, study designs, and intended conclusions.
- Learn why patient perspectives matter when assessing treatment benefits and the practical challenges of clinical care.
- Recognise common planning mistakes that can delay access and reduce the impact of otherwise strong research.
Episode Highlights With Timestamp
- 02:23 — From pure mathematics to patient-focused evidence Gorana shares how her career across statistics, epidemiology, and pharmaceutical functions shaped her approach to evidence generation.
- 04:29 — What makes an evidence plan integrated? We discuss a shared strategic roadmap that connects different methods and stakeholder needs throughout the product life cycle.
- 07:17 — Why evidence planning should start in research Gorana explains how early collaboration helps teams understand unmet needs, disease burden, and how to measure success.
- 15:56 — Balancing expert advice with real-world data We explore how advisory boards can guide research—and why their observations may not tell the whole story.
- 18:49 — Aligning evidence needs before launch We discuss why early input from market access, medical affairs, and other functions matters when choosing endpoints and study designs.
- 25:59 — What changes after a treatment reaches patients? We examine how clinical practice reveals new questions about tolerability, treatment burden, and outcomes beyond trial populations.
- 29:44 — Common mistakes and how to avoid them Gorana shares why starting too late, working in silos, and unclear communication can undermine integrated evidence planning.
Links and Resources
- Merck Healthcare
- The Effective Statistician
- The Effective Statistician Academy — Explore the Academy and its learning resources. The Effective Statistician
- Join PSI — Learn about membership in the statistical community supporting healthcare research. psiweb.org
- Further reading: Integrated Evidence Planning for Enhancing Patient Care — Harnessing the Power of Real-World Evidence — A related publication co-authored by Gorana Capkun. PMC
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