Video-on-Demand Library


Collection
Keyword or phrase

Topic

12 December 2024

Andrew Grieve and Zhiwei Zhang present their recent work. With the webinar chaired by Jenny Devenport.

Read more...

Papers for discussion:

Andrew Grieve
: Probability of success and group sequential designs - https://onlinelibrary.wiley.com/doi/10.1002/pst.2346

Zhiwei Zhang, Carrie Nielson, Ching-Yi Chuo & Zhishen Ye: Information-based group sequential design for post-market safety monitoring of medical products using real world data - https://onlinelibrary.wiley.com/doi/10.1002/pst.2385

11 December 2024

This month Zachary Skrivanek is presenting various ways to display reliability of measurements across raters and methods. This includes accuracy, precision and agreement. Visualisations are available on the Wonderful Wednesday blog.

Read more...

First some plots are shown to explore the data. Showing the individual data helps to avoid misinterpretations. For the actual comparison of the measurements the Bland-Altman plots are suited best. Further data exploration is supported by adding interactive highlighting to this and other plots. The next challenge is to find the best healthcare related visualisation of 2024. See the Wonderful Wednesday homepage for more detail.

Wonderful Wednesdays are brought to you by the Visualisation SIG. The Wonderful Wednesday team includes: Bodo Kirsch, Zachary Skrivanek, Lorenz Uhlmann, Steve Mallett, Rhys Warham, Mark Baillie, Paolo Eusebi, Martin Brown, Benjamin Lang


27 November 2024

5) Short summary to appear alongside the video on the video-on-demand homepage: The 7 Habits of Highly Effective People has had a profound impact on millions of people around the world. Over the past few months, members of the PSI Book Club have been exploring these transformative principles through focused discussions and real-world applications. In this upcoming session, we’ll bring these discussions to a broader audience. Together with our panel guests, we’ll explore how to practically apply the 7 Habits in our professional lives, share key insights from our book club sessions, and reflect on how these timeless principles can enhance both our personal and professional journeys.

Read more...

Emma May, Holly Prescott, Marius Sieverding, Alun Bedding, Steve Mallett

The 7 Habits of Highly Effective People has had a profound impact on millions of people around the world.  The book focuses on cultivating character and refining personality. Its principles are not only transformative for personal growth but also serve as powerful tools for professional development.  Over the past few months, the PSI Book Club has been deeply engaged in exploring these transformative principles. Through small group discussions, members have examined real-world applications, shared personal insights, and unpacked the key lessons embedded in these habits.  In this session, we’ll bring those rich discussions to the forefront. Our focus will be on how these principles can be effectively applied in the professional realm, driving leadership, teamwork, and personal growth. We are excited to welcome two esteemed guests: Alun Bedding, [Executive Coach and Consultant, former Global Head of Statistical Methods Collaboration and Outreach at Roche], and Steve Malett, [Senior Manager Statistics at Veramed]. Both Alun and Steve bring extensive industry experience and have served as facilitators for “The 7 Habits” discussions within the PSI Book Club.  Join us for an insightful conversation on why these habits remain relevant today, how they’ve impacted members of our book club, and how you can apply them in your own life. This is also an excellent opportunity to engage with our panel experts, ask questions, and gain practical advice for your personal and professional journey.

26 November 2024

The replacement of concurrent control animals by so-called Virtual Control Groups (VCGs) may reduce the use of animals in systemic toxicity studies and contributes to the 3R's principle of animal experimentation. However, the idea of replacing living beings with virtual data from historical data sets has so far not been introduced into the design of regulatory animal studies. Major steps facilitating review of methodology for derivation of ViCoGs from historical control data and performance testing in statistical analysis, are the collection, curation and sharing of suitable sets of historical control data from preclinical toxicity studies. This talk will summarize accomplished and ongoing efforts for cross-industry provision of data resources, standardization and curation activities and line out both general ideas and specific methodology for derivation of ViCoGs. Moreover, a discussion of advantages, pitfalls, real-world examples, potential solutions is given and ideas for transferring these insights into regulations and guidelines are presented.

Read more...

Lea Vaas

The replacement of concurrent control animals by so-called Virtual Control Groups (VCGs) may reduce the use of animals in systemic toxicity studies and contributes to the 3R's principle of animal experimentation. However, the idea of replacing living beings with virtual data from historical data sets has so far not been introduced into the design of regulatory animal studies. Major steps facilitating review of methodology for derivation of ViCoGs from historical control data and performance testing in statistical analysis, are the collection, curation and sharing of suitable sets of historical control data from preclinical toxicity studies. This talk will summarize accomplished and ongoing efforts for cross-industry provision of data resources, standardization and curation activities and line out both general ideas and specific methodology for derivation of ViCoGs. Moreover, a discussion of advantages, pitfalls, real-world examples, potential solutions is given and ideas for transferring these insights into regulations and guidelines are presented.

20 November 2024

With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

Read more...

Professor Nick Andrews

With an increasing number of vaccines recommended in pregnancy it is important to consider how best to evaluate safety. There are particular challenges in assessing safety in pregnancy such as healthy vaccinee effects, immortal time bias and biases introduced in the days close to birth. In this talk I will discuss these challenges and consider different designs with pros and cons, this will include presenting a study I have done using a nested case -control study within a cohort for Covid-19 vaccine safety and plans for a target trial emulation approach for assessing RSV vaccine in pregnancy.

19 November 2024

In this webinar, three speakers will share their perspective on the using of causal inference methodology in the analysis of RCT data. The audience will be presented with ideas and opportunities on why and how to apply causal inference principles / techniques in their work. And more importantly how causal approaches can help evaluating evidence for answers to causal-by-nature scientific questions.

Read more...

Sanne Roels, Tim Morris, Kelly van Lancker (hosts) Kaspar Rufibach (Merck), Susan Gruber (TL revolution) and Florian Lasch (EMA)

First, Kaspar Rufibach (Merck) shared his perspectives on opportunities to apply causal methods. Next, Susan Gruber (TL revolution) discussed targeted learning as a framework to address causal questions and the importance of sensitivity analyses. Finally, Florian Lasch (EMA) discussed both the importance of the causal inference angle in determining estimands, and will discuss a case study.  The webinar ended with a panel discussion. 

13 November 2024

It is not hard to find a bad visualisation. But how can you effectively improve it? Lorenz Uhlmann is presenting the positive effects of applying gestalt principles. Visualisations are available on the Wonderful Wednesday blog.

Read more...

Several design choices must be made while creating a visualisation. Bar chart or line plot? Faceted plots or overplotting? Should there be used multiple colours? And if yes, what colour scheme is best? How to optimize axes, legend, background and title? See the step-by-step improvement. The next challenge will be about intra- and interrater reliability. See the Wonderful Wednesday homepage for more detail.

Wonderful Wednesdays are brought to you by the Visualisation SIG. The Wonderful Wednesday team includes: Bodo Kirsch, Zachary Skrivanek, Lorenz Uhlmann, Steve Mallett, Rhys Warham, Mark Baillie, Paolo Eusebi, Martin Brown, Benjamin Lang


23 October 2024

This webinar discusses the complexities and opportunities of clinical trials with hierarchical composite endpoints, covering topics such as win odds, win ratio, net benefit as well as regulatory considerations when defining hierarchical composite endpoints.

Read more...

Margaret Gamalo, Cordula Zeller, Patrick Schlömer, Dali Zhou

This webinar discusses the complexities and opportunities of clinical trials with hierarchical composite endpoints, covering topics such as win odds, win ratio, net benefit as well as regulatory considerations when defining hierarchical composite endpoints. This webinar starts with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations are illustrated through case studies from clinical trials in heart failure and chronic kidney disease. The webinar concludes with a discussion and a Q&A.

17 October 2024

In this webinar we will review the range of statistical methodologies used to harness the potential of Real-World Data (RWD) in clinical development, particularly in the context of rare diseases and small populations like paediatrics. The session will include theoretical understanding and practical case studies, with a special focus on Bayesian methods and causal inference.

Read more...

In this webinar we will review the range of statistical methodologies used to harness the potential of Real-World Data (RWD) in clinical development, particularly in the context of rare diseases and small populations like paediatrics. The session will include theoretical understanding and practical case studies, with a special focus on Bayesian methods and causal inference.    

09 October 2024

It has been shown that certain patients benefit more from specific drugs while others suffer more heavily from side effects. Personalised dosing could address this issue. Steve Mallett is presenting visualisations that support the identification of patient groups with differential dose-response profile. Visualisations are available on the Wonderful Wednesday blog.

Read more...

The interactive Shiny application DoRiS was specifically designed to explore the dose-response in subgroups. It combines the display of summary level data, individual data, and statistical probability. Other proposals were to use augmented box plots, combined box and violin plots, or matrix plots across the subgroup factors.

The next challenge is about improving a plot of longitudinal data. See the Wonderful Wednesday homepage for more detail.

Wonderful Wednesdays are brought to you by the Visualisation SIG. The Wonderful Wednesday team includes: Bodo Kirsch, Zachary Skrivanek, Lorenz Uhlmann, Steve Mallett, Rhys Warham, Mark Baillie, Paolo Eusebi, Martin Brown, Benjamin Lang


08 October 2024

We will illustrate this with a case study example on testing the toxicity of an oncology formulation in a preclinical setting. This (simulated) study examines the impact of various formulation factors and their interactions on the toxicity and efficacy of a new oncology drug cocktail using a rat model. Key factors include the concentrations of Erlotinib, Cisplatin, and Dexamethasone, with responses measured such as tumor inhibition rate, overall survival rate, and toxicity indicators. Additionally, the pH of the formulation and particle size were evaluated. Responses measured include efficacy, represented by tumor inhibition rate, and various toxicity parameters, such as overall survival rate, hepatic toxicity, renal toxicity, cardiac toxicity, and hematological toxicity.

Read more...

Phil Kay and Chandramouli Ramnarayanan, JMP

Advances in AI, lab automation and closed-loop optimization promise big productivity gains for pharma R&D. But experimenting with maximum efficiency - that is, the least number of runs - will always be important. This is especially true where there is an ethical imperative, such as in pre-clinical animal experiments.  Recent advances in statistical Design Of Experiments (DOE) including Definitive Screening Designs (DSDs) and the broader class of Orthogonal Minimally Aliasing Response Surface (OMARS) designs have given us new options for understanding complex systems with small experiments. Self-Validated Ensemble Modelling (SVEM) is an innovative analysis approach that applies ideas from Machine Learning to small data from designed experiments. In this presentation we will show how SVEM works and how it can overcome common challenges when you are building useful models of complex systems from small experiments.

12 September 2024

PSI Journal Club presents “Subgroup and Covariate Analysis”. Chaired by Chris Harbron with presentations from: Thomas Jemielita: - Investigating Stability in Subgroup Identification for Stratified Medicine and Björn Holzhauer: - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials.

Read more...

PSI Journal Club presents “Subgroup and Covariate Analysis”. Chaired by Chris Harbron with presentations from: Thomas Jemielita: - Investigating Stability in Subgroup Identification for Stratified Medicine and Björn Holzhauer: - “Super-covariates”: Using predicted control group outcome as a covariate in randomized clinical trials.
Page:

Upcoming Events