How to Build an Effective Patient-Reported Outcome Strategy for Clinical Trials

A conversation with Julia Poritz

Why you should listen

You’ll learn:

• Learn how to build a cohesive patient-reported outcome strategy from measure selection through publication.
• Choose PRO measures that reflect what truly matters to patients.
• Capture treatment effects that traditional clinical endpoints may overlook.
• Understand how regulatory, payer, and clinical trial requirements influence PRO planning.
• Avoid common mistakes involving patient burden, translation, analysis, and reporting.
• Generate PRO evidence that is scientifically rigorous, comparable, and meaningful to patients.

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Episode highlights with timestamps

• 01:29 – The Role of Patient-Reported Outcomes
• Julia shares how PROs help bring the patient voice into clinical research.
• 04:19 – Connecting Treatment to Quality of Life
• We discuss a useful framework for understanding how treatment can affect symptoms, functioning, and patients’ overall well-being.
• 08:59 – Building a Cohesive PRO Strategy
• Julia introduces the essential areas researchers should consider when planning their approach.
• 15:00 – Common Challenges in PRO Planning
• We explore practical issues involving implementation, translation, and international studies.
• 16:23 – When Should PRO Planning Begin?
• Julia explains why timing matters and what development teams should consider when introducing PRO measures.
• 19:14 – Keeping Patients at the Center
• We close with the most important principle behind every effective PRO strategy.

Links and Resources:

🔗 PROTEUS Toolbox: Patient-Reported Outcomes Tools, Engaging Users and Stakeholders

🔗 National Cancer Institute: Introducing the PROTEUS Toolbox

🔗 CONSORT Reporting Guidelines

🔗 STROBE Reporting Guidelines

🔗 PRISMA Reporting Guidelines

🔗 The Effective Statistician Academy – I offer free and premium resources to help you become a more effective statistician.

🔗 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.

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