Integrated Evidence Planning That Connects Drug Development to Patient Needs

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