Event

PSI Webinar: Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance

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Date: Tuesday 3rd June 2025
Time: 14:00 - 15:00 BST
Location: Online via Zoom

Who is this event intended for?: Clinical pharmacology trial teams or those with a general interest in estimands.

What is the benefit of attending?: Attendees will have a better understanding of applying the estimand framework in clinical pharmacology trials.

Overview

Are you involved in designing or writing clinical pharmacology protocols? Then don't miss this webinar! We'll focus on the core concepts of estimands, specifically aimed at clinical trial development teams – no heavy statistical jargon required.

Join the expert authors of a recent paper [1] as they introduce the game-changing concepts of the “estimand framework” [2], "intercurrent events" [2], and the estimand thinking process. In this beginner-friendly session, you'll learn, step-by-step, how to apply estimand thinking to your trials, leading to clearer objectives and more meaningful results.

We'll dive into a practical case study – a bioequivalence trial – to illustrate how the estimand framework can eliminate ambiguity and bring greater transparency to the key clinical questions you're investigating. Beyond this specific example, we'll discuss the broader impact of estimands on various clinical pharmacology trials.

Come ready to learn and ask questions! The presenters will be joined by some of their co-authors for an interactive Q&A session after the presentation.

References:
[1] Applying the estimand framework to clinical pharmacology trials with a case study in bioequivalence - Lynggaard - 2025 - British Journal of Clinical Pharmacology - Wiley Online Library

[2] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials E9(R1). https://database.ich.org/sites/default/files/E9-R1_Step4_Guideline_2019_1203.pdf. Published November 2019

Cost

This webinar is free to both Members of PSI and Non-Members.

Registration

To register for this event, please click here.

Speaker details


Speaker

Biography
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Sue McKendrick, PPD Clinical Research Services

 Sue McKendrick is a Statistical Science Director with over 30 years of industry experience in statistical consultancy across all aspects of drug development including extensive experience in PK/PD.  She has presented on estimands at various conferences over the last 5 years and led a recent PSI workshop on estimands.  Sue leads the Estimand Working Group at PPD and has practical experience of dozens of studies with estimands.
Mark
Mark Baird, PPD Clinical Research Services

 
Mark Baird is Director of Clinical Pharmacology at PPD™ clinical research business of Thermo Fisher Scientific and has over 23 years’ experience manging global teams and providing oversight and guidance across all aspects of clinical pharmacology study design, data collection, PK/PD analysis and reporting.
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Helle Lynggaard, Novo Nordisk

 Helle Lynggaard is a key driver in implementing estimands in Novo Nordisk studies. Helle is an active member of many EIWG sub-teams including Estimands in Clinical Pharmacology and Early Phase Trials.
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David Wright, AstraZeneca

 
David Wright is Head of Statistical Innovation at AstraZeneca. Previously David worked for the MHRA for 16 years where he was the Chair of the Biostatistics Working Party and led the revision of the CHMP guideline on missing data in confirmatory clinical trials. This work sparked his interest in Estimands particularly on how to use the proposed framework in practice.
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Judith Anzures-Cabrera, Roche Products Ltd
Judith Anzures-Cabrera, a statistician with 16 years at Roche, has worked on several therapeutic areas, focusing on Parkinson's Disease since 2019. Judith represents Roche at the EIWG. Prior to Roche, she worked at the MRC Biostatistics Unit in Cambridge and obtained her PhD from the University of Warwick.


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