The Effective Statistician - in association with PSI

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

Listen Later
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
        View all episodesView all episodes
        Download on the App Store
        The Effective Statistician - in association with PSIBy Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
        • 4.4
        • 4.4
        • 4.4
        • 4.4
        • 4.4

        4.4

        9 ratings

        More shows like The Effective Statistician - in association with PSI

        View all
        Stuff You Should Know by iHeartPodcasts

        Stuff You Should Know

        78,657 Listeners

        Freakonomics Radio by Freakonomics Radio + Stitcher

        Freakonomics Radio

        32,092 Listeners

        Planet Money by NPR

        Planet Money

        30,683 Listeners

        Hidden Brain by Hidden Brain, Shankar Vedantam

        Hidden Brain

        43,563 Listeners

        Pivot by New York Magazine

        Pivot

        9,634 Listeners

        JAMA Clinical Reviews by JAMA Network

        JAMA Clinical Reviews

        508 Listeners

        HBR IdeaCast by Harvard Business Review

        HBR IdeaCast

        152 Listeners

        Page 94: The Private Eye Podcast by Page 94: The Private Eye Podcast

        Page 94: The Private Eye Podcast

        396 Listeners

        The Peter Attia Drive by Peter Attia, MD

        The Peter Attia Drive

        8,017 Listeners

        The Journal. by The Wall Street Journal & Spotify Studios

        The Journal.

        6,089 Listeners

        Huberman Lab by Scicomm Media

        Huberman Lab

        29,230 Listeners

        Biotech Hangout by Daphne Zohar, Josh Schimmer, Brad Loncar, Tim Opler and more

        Biotech Hangout

        23 Listeners

        The Rest Is Politics by Goalhanger

        The Rest Is Politics

        3,327 Listeners

        DER TRUMP EFFEKT by ZDF auslandsjournal

        DER TRUMP EFFEKT

        19 Listeners

        Die OpenAI Story by Deutschlandfunk

        Die OpenAI Story

        32 Listeners