Video-on-Demand Library


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17 November 2021

In this webinar we look at some recent advances in statistical methods for identifying treatment effect heterogeneity in clinical trials. This ranges from identifying baseline biomarkers likely to influence the treatment effect (ranking) to provide novel biomarker 'signatures' (subgroups) with associated estimated enhanced effect (Individual Treatment Effects).

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David Svensson (AstraZeneca), Ilya Lipkovich (Eli Lilly), Björn Bornkamp (Norvatis), Kostas Sechidis (Novartis), Paolo Eusebi (UCB Pharma)

In this webinar we look at some recent advances in statistical methods for identifying treatment effect heterogeneity in clinical trials. This ranges from identifying baseline biomarkers likely to influence the treatment effect (ranking) to provide novel biomarker 'signatures' (subgroups) with associated estimated enhanced effect (Individual Treatment Effects). Some practical issues ranges from overfitting risks, biases, and confounding of prognostic and predictive effects. Modern methods aim to overcome such potential difficulties while remaining flexible, and offer a structured approach to the problem (aiming to avoid the notorious 'data dredging'). The novel techniques are often tree based and/or penalized regression, i.e., with a machine learning flavour. Sometimes the aim of the analysis is to predict the individual optimal treatment allocation given baseline biomarker data (Individual Treatment Rules). Efficient Visualization of relationships in the data is also of importance in the practical applications. The talks will highlight and discuss such aspects and will also reflect typical aspects discussed within the EFSPI/PSI Subgroup Special Interest Group. (While this event is not intended as a formal course, it will still serve as an introduction and overview to the area, as well as covering some more technically challenging material for the more experienced participant).

28 October 2021

Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.

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Prof. Dan-Yu Lin 

Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. However, the high vaccine efficacy reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm. Here, we show how to estimate potentially time-varying placebo-controlled vaccine efficacy in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term vaccine efficacy.  

21 October 2021

PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Complex Innovative Designs (CID) in practice. Speakers from regulatory authorities and industry will present on their experience.

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John Scott, Dieter Häring, Marius Thomas, Olivier Collignon

PSI, the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and the Biopharmaceutical Section of the American Statistical Association (ASA) are jointly organising a webinar on Complex Innovative Designs (CID) in practice. Speakers from regulatory authorities and industry will present on their experience.
The following aspects are covered:
• Overview of the FDA Complex Innovative Trial Design pilot program and the applications received to date together with details on some of them
• Overview of the FDA guidance on interacting on Complex Innovative Trial Designs
• Detailed case study of a clinical trial in children which was evaluated within FDA’s CID pilot program, applying borrowing of information from external trials in adults
• Overview of statistical and regulatory considerations on master protocols, focusing on Phase III confirmatory trials

21 October 2021

Imposter Syndrome is experienced by 70% of people and the feelings of self-doubt and inadequacy it promotes can hold us back from valuing our accomplishments and reaching our full potential. Learn from others in the PSI Community who also associate with Imposter Syndrome.

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Kimberley Hacquoil, Chrissie Fletcher, Paul Terrill, Claire Brittain, Anashua Banerji

Do you ever think: “I don’t belong here, I’m not as capable as they think I am” “I don’t deserve it, I’m just lucky” “I'm never good enough, others are better” “I’m a fraud, I’ll get found out”. Imposter Syndrome is experienced by 70% of people and the feelings of self-doubt and inadequacy it promotes can hold us back from valuing our accomplishments and reaching our full potential. Learn from others in the PSI Community who also associate with Imposter Syndrome. They will discuss the topic, give their own personal views and experiences and provide tips to beat it.

13 October 2021

Bodo Kirsch discusses an approach to display data on competing risks based on an issue recently published. Visualisations are available on the Wonderful Wednesday blog.

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Bodo Kirsch discusses an approach to display data on competing risks based on an issue recently published. Visualisations are available on the Wonderful Wednesday blog

The proposed visualization by Agustin Calatroni consists of two parts. The first one gives a general overview on baseline parameters in a graphic-table-combination  (grable) with interactive histograms. The second part shows the impact of this parameters on the different risks in another grable with expandable CIF display. Different possibilities for layout, coloring and description are discussed.

The challenge for November is about displaying clinically relevant differences based on a data example with two scores. How to visually communicate relevant changes in one score using the second as anchor? 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, Alexander Schacht, Mark Baillie, Daniel Saure, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, Markus Vogler, David Carr, Steve Mallett, Abi Williams, Julia Igel, Gakava Lovemore, Katie Murphy, Rhys Warham, Sara Zari, Irene de la Torre Arenas

17 September 2021

Gain new insights into data visualisations and learn about the regulatory perspective with this event, which provides a practical introduction to modern methods of data visualisation, including presentations from some well-known and influential speakers.

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Data visualisation has been used to gain insights into medical data for over 150 years. More modern methods include interactive and animated data visualisation tools, and the development of open source code using agile methods. Gain new insights into data visualisations and learn about the regulatory perspective with this event, which provides a practical introduction to modern methods of data visualisation, including presentations from some well-known and influential speakers.

Key Timestamps:

00:16 Welcome & Introduction
04:00 Susan Mayo - Making impactful graphs: Looking through the eyes of your audience
58:00 Jeremy Wildfire - Building Open-Source Tools for Safety Monitoring 
1:39:40 Sheila Dickinson - Points to bear in mind for visual displays of benefit-risk data
2:07:50 Matthias Trampisch - Dynamic data visualization for Benefit/Risk Assessment DURING trial conduct
2:15:30 Charlotta Fruechtenicht - visR: A Package for Effective Visualizations in Pharma
2:33:35 Patrick Schlömer - A concept to foster interactive and interdisciplinary data investigations using intelligent visualizations
3:00:10 Panel Q&A Discussion

08 September 2021

The Wonderful Wednesday of September is about the display of treatment differences in time-series data on the example of Continuous Glucose Monitoring (CGM) data. Zachary Skrivanek presents the visualisations proposed for this challenger ranging from explanatory plots with condensed information to an exploratory interactive dashboard. All visualisations are available on the Wonderful Wednesday blog.

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The Wonderful Wednesday of September is about the display of treatment differences in time-series data on the example of Continuous Glucose Monitoring  (CGM) data. Zachary Skrivanek presents the visualisations proposed for this challenger ranging from explanatory plots with condensed information to an exploratory interactive dashboard. All visualisations are available on the Wonderful Wednesday blog.

The main message of successful glycemic control is nicely transported in a box plot using intuitive coloring. For a detailed look at the subject level data the CGM dashboard gives the possibility to combine different displays while being able to sort and filter the data. In addition it plots the results of recursive partitioning models that can be interactively applied to a huge set of parameters.

Last but not least a set of different multi-plots are discussed highlighting pros and cons of overlayed bands, averages, modelled averages, and scatter plots. This includes the usage of various visual elements as well as effective decluttering of a visualisation.

The October challenge is on a competing risk in a recent COVID-19 data example. How to find a way to display the impact of different risk factors on the risk of death considering the competing risk of recovery? 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, Alexander Schacht, Mark Baillie, Daniel Saure, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, Markus Vogler, David Carr, Steve Mallett, Abi Williams, Julia Igel, Gakava Lovemore, Katie Murphy, Rhys Warham, Sara Zari, Irene de la Torre Arenas



11 August 2021

For this edition of the Wonderful Wednesdays, the audience was asked to send examples of visualizations representing coronavirus data. Mark Baillie guided the webinar, showcasing different types of visualizations, such as area graphs, forest plots, streamgraphs, or network analysis. All visualizations are available on the Wonderful Wednesday blog.

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For this edition of the Wonderful Wednesdays, the audience was asked to send examples of visualizations representing coronavirus data. Mark Baillie guided the webinar, showcasing different types of visualizations, such as area graphs, forest plots, streamgraphs, or network analysis. All visualizations are available on the Wonderful Wednesday blog.

The webinar starts by showing an example of a governmental COVID dashboard. Clean and straight to the point, the UK site provides information about the pandemic in the country. It includes numbers and texts that answer the main questions that users might have: are cases rising? What are the vaccinations rates? By clicking each of the topics, users can see specific information in the form of interactive charts. 

The next visualization, by the Financial Times, represents the excess of deaths caused by the Coronavirus pandemic. It shows a set of small multiples -one per country- highlighting when the number of deaths was higher than the average in recent years. Although the information is impressive, the chart is very crowded with data and annotations which makes understanding it a bit difficult. A similar project, done by The Economist, included interactivity to avoid this problem. Their implementation of tooltips to extract information is very well done.

The following visualization is an unusual chart done again by The Financial Times: a streamgraph. This type of plot is a stacked area chart displaced around a central axis. Its organic shapes and different looks might make them unconventional and attractive. However, with this type of chart is difficult to compare the size of the areas. And users who are not familiarized with them might have a hard time understanding them.

But visualizing the coronavirus pandemic doesn’t mean using rare charts, or interactive projects. One forest plot from The Economist shows how this traditional chart can be extremely successful at highlighting stories. The key is to include labels and annotations to make the information accessible and declutter the axis to make the data be the main protagonist.

Many of the projects around COVID used gamification and interactivity to explain complex scientific terms to the general audience. The webinar highlighted two that explained how the virus can expand slower or faster depending on people staying or not at home. Users can understand better how simulations and models work by interacting with the different variables that feed the interactive visualizations.

The last example is a network analysis of how the virus moved in Hong Kong during the different waves.

14 July 2021

Abi Williams presents the visualisations of the SDQ-12 in conjunction with different anchor measures. For this challenge very different plot types have been proposed. All visualisations are available on the Wonderful Wednesday blog.

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Abi Williams presents the visualisations of the SDQ-12 in conjunction with different anchor measures. For this challenge very different plot types have been proposed. All visualisations are available on the Wonderful Wednesday blog.

Two ways of multiplot staggered bar charts are shown to get a quick overview of the SDQ-12 data. The waterfall plot nicely displayed the relation of the SDQ change to the self-reported outcome. A network plot showed the relation to the other anchor measurements. And then there is that great interactive tool with multiple display options including a plot like it’s used for the principle compound analyses and a scatterplot matrix using also mosaic plots for the categorical variables. Last but not least a wright map visualised the item response models. The new challenge is asking for your favorite plot around COVID-19. Where have you seen it? What do you like about it? How could it even be improved?

Wonderful Wednesdays are brought to you by the Visualisation SIG. The Wonderful Wednesday team includes: Bodo Kirsch, Alexander Schacht, Mark Baillie, Daniel Saure, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, Markus Vogler, David Carr, Steve Mallett, Abi Williams, Julia Igel, Gakava Lovemore, Katie Murphy, Rhys Warham, Sara Zari, Irene de la Torre Arenas.

06 July 2021

Watch Chris Harbron (Roche) and Margaret Gamalo (Pfizer) present their recent work. The webinar will be chaired by Elizabeth Williamson (London School of Hygiene and Tropical Medicine).

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Watch Chris Harbron (Roche) and Margaret Gamalo (Pfizer) present their recent work. The webinar will be chaired by Elizabeth Williamson (London School of Hygiene and Tropical Medicine).

06 July 2021

View now to find out about all the exciting events and content PSI have got planned for the rest of this year and beyond.

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This year's Annual General Meeting focused on how PSI has navigated the challenges of the past year and adapted to the new online world, as well as how we plan to embrace a new Board structure and new opportunities as we move forward. View now to find out about all the exciting events and content PSI have got planned for the rest of this year and beyond.

29 June 2021

This presentation gives some background regarding the ‘Carcinogenicity Statistics Discussion Group’, which is an industry group started by the ‘Nonclinical Biostatistics Leadership Forum’. The talk reviews the history of the group, outlines the current status, and gives an overview of the types of topics discussed. Highlights from some past discussion topics are also reviewed.

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Steven Bailey

This presentation gives some background regarding the ‘Carcinogenicity Statistics Discussion Group’, which is an industry group started by the ‘Nonclinical Biostatistics Leadership Forum’. The talk reviews the history of the group, outlines the current status, and gives an overview of the types of topics discussed. Highlights from some past discussion topics are also reviewed.
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