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. * * * ### 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*](https://theeffectivestatisticianleadershipprogram.teachable.com/ "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*](https://cold-dew-4466.kit.com/025bb30cd1 "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. **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. **Subscribe & Stay Updated:** Never miss an episode! Subscribe to *The Effective Statistician* on your favorite podcast platform and continue growing your influence as a statistician.