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08 July 2026

This month’s webinar focuses on the use of data visualisation to characterise the pharmacokinetic behaviour of a drug. Rhys Warham leads the discussion, joined by Steve Mallett. All visualisations are available on the Wonderful Wednesday blog.

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Two submissions are discussed, comprising multiple data visualisations. Both submissions include interactive components allowing the user to explore the data. Discussion topics include exploratory vs explanatory data visualisations and the potential benefits of ‘storytelling’ with data visualisation to communicate a message. The challenge for the next webinar was set, which will be to use visualisations to communicate the impact of a protocol amendment in a hypothetical trial. See the Wonderful Wednesday homepage for more details.

Wonderful Wednesdays are brought to you by the Visualisation SIG. The Wonderful Wednesday team includes Bodo Kirsch, Steve Mallett, Rhys Warham, Lovemore Gakava, Zara Sari, Farzaneh Safavimanesh, Zachary Skrivanek, Lorenz Uhlmann and Paolo Eusebi



30 June 2026

This webinar will discuss modern approaches to covariate adjustment in clinical trials. We begin with the motivation and key principles underlying the FDA guidance, then revisit established methodologies in light of these regulatory considerations. Building on this foundation, we explore extensions to more advanced applications in clinical trial analysis. The webinar concludes with an outlook on future developments and a panel discussion.

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This webinar provides a comprehensive overview of covariate adjustment in clinical trials, covering both regulatory foundations and recent methodological developments. The session opens with an introduction (Daniel Rubin, FDA) to the potential gains from covariate adjustment and discuss key recommendations from the 2023 FDA guidance. This includes considerations for both linear and non-linear models, as well as areas where further research may help refine best practices for registrational trials.

Building on this foundation, Dominic Magirr (Novartis) will review well-accepted methods for covariate adjustment, including standardization (g-computation) using generalized linear models, and covariate-adjusted extensions of the log-rank test with corresponding hazard ratio estimation. The presentation will also highlight the distinction between marginal and conditional estimands and discuss the potential role of prognostic risk scores or “supercovariates.”

The webinar then moves to recent methodological developments beyond current standard practice. Sanne Roels (Johnson & Johnson) will explore extensions such as covariate adjustment in group sequential designs, with particular attention to type I error control, and discuss the move toward data-adaptive approaches, including pre-specified strategies such as Targeted Minimum Loss-Based Estimation (TMLE) across common endpoint types.

Looking ahead, Marlena Bannick (Fred Hutch (Incoming) / University of Washington) will link these future directions with practical implementation. The talk will introduce the RobinCar Family of R packages and discuss the use of machine learning, handling of missing data, and adjustments for small sample sizes. The talk will also discuss promising future directions including covariate adjustment for time-to-event outcomes and how covariate adjustment can be implemented in trials with complex and innovative designs.

The session concludes with a panel discussion led by Jürgen Hummel (Cytel), bringing together regulatory, industry, and academic perspectives to reflect on current practice and future directions in covariate adjustment.

17 June 2026

Chair: Ian Wadsworth, Phastar Efficient modelling of complex responder endpoints to improve trial power - James Wason, Newcastle University Beyond Dichotomization: Efficient estimation of response rates using continuous outcomes - Michael Sweeting, GSK A robustness assessment of the latent variable framework for composite endpoints: With application to late-stage trials - Paul Newcombe, GSK

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Chair: Ian Wadsworth, Phastar
Efficient modelling of complex responder endpoints to improve trial power - James Wason, Newcastle University
Beyond Dichotomization: Efficient estimation of response rates using continuous outcomes - Michael Sweeting, GSK 
 A robustness assessment of the latent variable framework for composite endpoints: With application to late-stage trials - Paul Newcombe, GSK

17 June 2026

Chair: Ayon Mukherjee, Eli Lilly Integrating preclinical insights for adaptive dose escalation in Phase I oncology trials: A methodological framework for enhanced efficiency - Melanie Guhl, Department of Statistical Methodology, Saryga Rigorous Type I error control for randomized BOP2-TE designs under minimal assumptions - Alexander Ooms, GSK A ballad of a basket trial and historical information borrowing: Application in neurodegenerative diseases - Libby Daniells, MRC Biostatistics Unit, University of Cambridge

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Chair: Ayon Mukherjee, Eli Lilly
Integrating preclinical insights for adaptive dose escalation in Phase I oncology trials: A methodological framework for enhanced efficiency - Melanie Guhl, Department of Statistical Methodology, Saryga 
Rigorous Type I error control for randomized BOP2-TE designs under minimal assumptions - Alexander Ooms, GSK
A ballad of a basket trial and historical information borrowing: Application in neurodegenerative diseases - Libby Daniells, MRC Biostatistics Unit, University of Cambridge

17 June 2026

Chair: Clelia Cahuzac, F. Hoffmann-La Roche Ltd Forecasting and cost-efficient designing restricted enrolment in clinical trials Vlad Anisimov, Amgen

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Chair: Clelia Cahuzac, F. Hoffmann-La Roche Ltd 
Forecasting and cost-efficient designing restricted enrolment in clinical trials
Vlad Anisimov, Amgen

17 June 2026

Chair: Kate Taylor, Amgen How statisticians can use the Growth Mindset Framework for stronger FSP success in pharma - Amy Spencer, MMS From Priors to Partnership: A Bayesian View of CRO-Sponsor Collaboration – Kimberley Hacquoil, Veramed From classroom to clinical trials: How PSI Schools is inspiring the next generation of statisticians - Ciara Lucas-Garner, Amgen From behind the screen to beside your team: Why the office still matters – Justyna Mlynarczyk, Phastar #FakeNews: Statisticians and the challenge of misinformation - Claire Brittain, Novartis The Career Habits of Building Leadership Behaviours - Emma May, The Career Habit

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Chair: Kate Taylor, Amgen
How statisticians can use the Growth Mindset Framework for stronger FSP success in pharma - Amy Spencer, MMS 
From Priors to Partnership: A Bayesian View of CRO-Sponsor Collaboration – Kimberley Hacquoil, Veramed
From classroom to clinical trials: How PSI Schools is inspiring the next generation of statisticians - Ciara Lucas-Garner, Amgen
From behind the screen to beside your team: Why the office still matters – Justyna Mlynarczyk, Phastar
#FakeNews: Statisticians and the challenge of misinformation - Claire Brittain, Novartis
The Career Habits of Building Leadership Behaviours - Emma May, The Career Habit

17 June 2026

Chair: Sue Todd, University of Reading A comparison of approaches to incorporate patient-selected and patient-ranked outcomes in clinical trials - David Robertson, MRC Biostatistics Unit, University of Cambridge Does your PRO sum it all up? Investigating the variability in item specific PRO effects using random item slopes regression - Tom Booth, Acaster Lloyd Timepoint selection for long term PRO data modelling in oncology trials - Anna Rigazio, IQVIA Impact of interval-censored data on comparative time-to-event endpoints: a simulation study applied to patient-reported outcomes in oncology - Joel Sims, Adelphi Values

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Chair: Sue Todd, University of Reading
A comparison of approaches to incorporate patient-selected and patient-ranked outcomes in clinical trials - David Robertson, MRC Biostatistics Unit, University of Cambridge
Does your PRO sum it all up? Investigating the variability in item specific PRO effects using random item slopes regression - Tom Booth, Acaster Lloyd
Timepoint selection for long term PRO data modelling in oncology trials - Anna Rigazio, IQVIA
Impact of interval-censored data on comparative time-to-event endpoints: a simulation study applied to patient-reported outcomes in oncology - Joel Sims, Adelphi Values

17 June 2026

Chair: Naomi Givens, GSK Dooti Roy, Boehringer Ingelheim Matthias Trampisch, Boehringer Ingelheim Florence Le Maulf, Cytel

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Chair: Naomi Givens, GSK
Dooti Roy, Boehringer Ingelheim
Matthias Trampisch, Boehringer Ingelheim
Florence Le Maulf, Cytel

17 June 2026

Chair: Simon Newsome, Novartis Eleanor Ralphs, IQVIA Josie Wolfram, Astellas Rima Izem, Novartis

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Chair: Simon Newsome, Novartis
Eleanor Ralphs, IQVIA
Josie Wolfram, Astellas
Rima Izem, Novartis

17 June 2026

Chair: Ian Wadsworth, Phastar Accelerating Alzheimer's research: a modular framework for exploring Bayesian disease progression models - Oana Petrof, GSK A comprehensive self-adaptive mixture prior approach to dynamic borrowing from external data - Alfredo Farjat, Bayer B.V. Information borrowing in Bayesian clinical trials: choice of tuning parameters for the robust mixture prior - Vivienn Weru, German Cancer Research Center (DKFZ) On the interplay between prior weight and variance of the robustification component in robust mixture prior Bayesian dynamic borrowing approach - Marco Ratta, Saryga

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Chair: Ian Wadsworth, Phastar
Accelerating Alzheimer's research: a modular framework for exploring Bayesian disease progression models - Oana Petrof, GSK
A comprehensive self-adaptive mixture prior approach to dynamic borrowing from external data - Alfredo Farjat, Bayer B.V.
Information borrowing in Bayesian clinical trials: choice of tuning parameters for the robust mixture prior - Vivienn Weru, German Cancer Research Center (DKFZ)
On the interplay between prior weight and variance of the robustification component in robust mixture prior Bayesian dynamic borrowing approach - Marco Ratta, Saryga

17 June 2026

Non-inferiority and equivalence comparisons in clinical trials Chair: David Wright, AstraZeneca Helle Lynggaard, Novo Nordisk Florian Lasch, EMA Use of external controls and real-world evidence to support regulatory decision making Chair: Rima Izem, Novartis Elina Asikanius, FIMEA Khadija Rantell, MHRA

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Non-inferiority and equivalence comparisons in clinical trials
Chair: David Wright, AstraZeneca
Helle Lynggaard, Novo Nordisk
Florian Lasch, EMA

Use of external controls and real-world evidence to support regulatory decision making
Chair: Rima Izem, Novartis
Elina Asikanius, FIMEA
Khadija Rantell, MHRA

16 June 2026

Chair: Simon Newsome, Novartis Novel bayesian prediction of event times using mixture model for blinded randomized controlled trials - Donia Skanji, Servier Assessing multiple endpoints using a novel software solution in a late-stage oncology study - Valeria Mazzanti, Cytel Inc. Developing a simulation-based decision framework for interpretation of interim survival data in oncology trials – Andrew Mills, MMS

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Chair: Simon Newsome, Novartis
Novel bayesian prediction of event times using mixture model for blinded randomized controlled trials - Donia Skanji, Servier
Assessing multiple endpoints using a novel software solution in a late-stage oncology study - Valeria Mazzanti, Cytel Inc.
Developing a simulation-based decision framework for interpretation of interim survival data in oncology trials – Andrew Mills, MMS 
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