The Effective Statistician - in association with PSI

Choosing and Interpreting PROs and COAs – A Guide for Clinical Trial Statisticians

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Interview with Rachael Lawrance

**

Why You Should Listen

**

**If you work in clinical trials or healthcare analytics, this episode will help you:
**

  • Understand why patient perspectives are now central—not optional
  • Learn the difference between PROs and COAs, and when each matters
  • See how questionnaires are scientifically developed and validated
  • Improve how you select, analyze, and interpret endpoints
  • Avoid common pitfalls when using patient-reported data
    • Episode Highlights
    • 00:00 – Introduction and background to the episode
    • 01:31 – Rachael’s journey into patient-centered outcomes
    • 03:24 – Why PROs have become central to drug development
    • 05:18 – What COAs are and how they extend beyond PROs
    • 05:46 – The four types of COAs explained
    • 08:58 – Generic vs disease-specific questionnaires
    • 13:16 – How PRO instruments are developed and validated
    • 15:06 – What “meaningful change” really means
    • 17:02 – Using Phase II data to inform Phase III endpoints
    • 18:24 – FDA expectations and guidance on PROs
    • 21:47 – Using the estimand framework for patient-centered endpoints
    • 23:15 – What “psychometrically sound” actually means
    • 31:16 – How I would choose the right PRO or COA for a trial
    • 34:01 – Avoiding missing data and reducing patient burden
    • 37:18 – Key takeaways on interpreting patient-reported data
      • About the Guest

      Rachael Lawrance

      Senior Director & Functional Lead Statistics, Patient-Centered Outcomes (PCO), Adelphi Values

      Rachael is a highly experienced statistician specializing in patient-centered outcomes. She works across the full lifecycle of PRO development—from qualitative research and questionnaire design to statistical validation and interpretation.

      With a background in pharma and consultancy, she focuses on bridging the gap between rigorous statistical methodology and meaningful patient insights.

      🔗 Links & References

      • Adelphi Values
      • The Effective Statistician
      • PSI Conference 2026
      • FDA Patient-Focused Drug Development (PFDD) Guidance Series
      • PRO Consortium (PRO-C) resources
        • ...more
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