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