The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

The Effective Statistician - in association with PSI

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

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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 – 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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About this podcast

The podcast from statisticians for statisticians to have a bigger impact at work. This podcast is set up in association with PSI - Promoting Statistical Insight. This podcast helps you to grow your leadership skills, learn about ongoing discussions in the scientific community, build you knowledge about the health sector and be more efficient at work. This podcast helps statisticians at all levels with and without management experience. It is targeted towards the health, but lots of topics will be important for the wider data scientists community.

by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry

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