Video-on-Demand Library


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11 May 2022

Lorenz Uhlmann is showing the results of the monthly challenge. It is all about a responder analysis on HiSCR where response is defined by three components. How to display the impact of changes in the definition on the result. All visualisations are available on the Wonderful Wednesday blog.

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Lorenz Uhlmann is showing the  results of the monthly challenge. It is all about a responder analysis on HiSCR where response is defined by three components. How to display the impact of changes in the definition on the result. All visualisations are available on the Wonderful Wednesday blog

Various ideas are presented starting with a percent grid chart, sometimes referenced as waffle plot. Visual perception changes if these are presented mirrored compared to side-by-side. Regular or hanging bar charts give a neat and clean massage by omitting clutter.  A connected scatter plot is enhanced with added box and violin plots. The impact of the different components is shown in a Trellis plot. Three apps are presented allowing for interactive changes of the outcome definition ranging from simple bar charts to RR/OR plots and a volcano plot. The next challenge is on pediatric growth 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, 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

28 April 2022

In this event, speakers will present different composite estimand strategies for clinical trials, the analyses that target these estimands, and regulatory considerations for clinical trials with composite estimands and endpoints.

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Khadija Rantell, Alex Ocampo, Samvel Gasparyan, Oliver Keene, Inês Antunes dos Reis 

When an intercurrent event in itself is considered to be informative about the treatments' effect on patients' outcomes, the intercurrent event is often incorporated into the definition of the variable. The ICH E9 (R1) addendum refers to this as the composite strategy. In this event, speakers will present different composite estimand strategies for clinical trials, the analyses that target these estimands (e.g., trimmed means, rank-based approaches), and regulatory considerations for clinical trials with composite estimands and endpoints. A discussant will reflect on the presentations.

26 April 2022

This journal club features two papers on the topic of “Treatment Switching in Clinical Trials”. Watch now to hear Franz König (Medical University of Vienna) and Juliane Manitz (EMD Serono) present their recent work.

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13 April 2022

The challenge of this month was to display COVID patient status over time as measured by the Ordinal Scale for Improvement. At the same time patients death or full recovery as well as patients leaving the hospital should be taken into account. All visualisations are available on the Wonderful Wednesday blog.

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The challenge of this month was to display COVID patient status over time as measured by the Ordinal Scale for Improvement. At the same time patients death or full recovery as well as patients leaving the hospital should be taken into account. All visualisations are available on the Wonderful Wednesday blog

The first example is a lasagne plot in combination with a frequency plot allowing for examining the individual data as well as summary statistics. Clear differentiation between worsening and improvement can be seen with a stacked area chart with shifted reference line. With the first shiny app the user can switch between line plot and area chart. The second shiny app combines a heatmap with a dendogram. The following discussion is around the usage of sequential versus divergent color schemes. The next challenge is on a binary endpoint based on three continuous components. 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.

12 April 2022

In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal. In this webinar we give an overview over the statistical optimal design approach in this context.

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Speaker: Tim Holland-Letz

In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal. In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously. Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.

29 March 2022

This PSI Lunch & Learn series focuses on career-related topics through a panel discussion. This webinar - "The Floating Ladder" - delves into whether the traditional career ladder is still relevant or whether you can build your own?

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Presenters: Amanda Darekar, Holly Tovey, Joanne Mann, Claire Brittain and Chetan Mistry.

Climbing the traditional Career Ladder has long been associated with career progression with the ultimate goal of moving into management. Statistics as a field has grown in prominence, especially in the last few years and with that growth we re-examine whether the traditional Career Ladder is still relevant. Hear from others in the PSI Community who look to forge their own path in the industry as a Statistician. They will give their own personal views and experiences on creating your own career path.

23 March 2022

The talks in this webinar will cover challenges related to study design, including estimands, and use of real-world data and evidence to supplement clinical trial data. Case studies of such challenges will be presented.

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Presenters: Chenxuan Zang, Shihua Wen, Gerry Downey

Research and clinical trials for gene therapies pose many specific challenges. These can be due to comparing potentially curative treatments to a standard of care with different modes of action or even no currently available treatments. There may also be small sample sizes due to rare or ultra-rare diseases. The talks in this webinar will cover challenges related to study design, including estimands, and use of real-world data and evidence to supplement clinical trial data. Case studies of such challenges will be presented.

22 March 2022

The FDA Real-World Evidence program outlines how RWD can be used to support regulatory decision making. Tacrolimus indication was expanded to Lung transplantation based solely on RWE. Three stakeholders – the sponsor, RWD vendor and FDA - share their experiences of the submission and approval process.

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Presenters: Tae Hyun Jung, U.S. Food and Drug Administration; Tim Weaver, Chronic Disease Research Group; Richard Croy, David Nimke, and Josephine Wolfram, Astellas

The FDA Real-World Evidence (RWE) Framework was published in Dec. 2018, shedding some light on how Real-World Data (RWD) can be used to support regulatory decision making. This guidance was greatly welcomed in an environment that focuses on efficiency and innovative trial designs. Yet, three years out, there are not many examples of RWE in practice, especially of situations where RWE is the exclusive source of evidence supporting new drug indications. In July 2021, tacrolimus was approved for Lung transplantation based solely on RWE and the involved parties share their experience with statisticians in the pharmaceutical community. Three stakeholders – the sponsor, RWD vendor and FDA - share their experiences of the submission and approval process. Topics covered include relevant project background & context, identification/selection of RWD, study design & key analysis methods, operational considerations related to study conduct & quality, submission content and labeling.

09 March 2022

Irene de la Torre Arenas moderates the anniversary edition of the Wonderful Wednesday Webinars. The panel members present the most-loved graphical displays of the last two years of WWW. All visualisations are available on the Wonderful Wednesday blog.

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Irene de la Torre Arenas moderates the anniversary edition of the Wonderful Wednesday Webinars. The panel members present the most-loved graphical displays of the last two years of WWW. All visualisations are available on the Wonderful Wednesday blog

Among the selected visualisations are the Interactive Model Studio, the AE upset plot, the DLQI line plot, a multiplot histogram, the Subgroup Explorer, improved bar charts and a forest-dot-plot.

There is a new challenge for April on a daily measured ordinal scale for improvement. 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

02 March 2022

An introduction to the event from the chair of PSI CALC, followed by a Panel Discussion featuring company volunteers.

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An introduction to the event from the chair of PSI CALC, followed by a Panel Discussion featuring company volunteers.
Presenters: Amanda Darekar, Emma Crawford, Jane Glibert, Jamie Inshaw, Jessica Kendall, Heather McCallum, Sam Moore, Jennifer Rogers.

22 February 2022

New Starter presentation - Clinical Trials Unit (CTU), presented by Rachel Phillip.

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22 February 2022

New Starter presentation - Contract Research Organisation (CRO), presented by Tabitha Bowman.

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