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