Video-on-Demand Library


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01 December 2022

The webinar aims to provide information on the purpose and methods for covariate adjustment in randomized clinical trials (RCTs).

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Jonathan Bartlett (London School of Hygiene & Tropical Medicine), Florian Voss (Boehringer Ingelheim), Rhian Daniel (Cardiff University), Tim Morris (MRC Clinical Trials Unit at UCL) and Seth Seegobin (AstraZeneca).

The webinar aims to provide information on the purpose and methods for covariate adjustment in randomized clinical trials (RCTs). 

The speakers will review and compare different approaches for adjusting for covariates in terms of the properties of the statistics, estimands, convergence and handling of missing data. The FDA's revised guidance on adjusting for covariates in RCTs and relevant commentary will be discussed with the objective to provide practical examples for analysis planning in studies. The speakers will offer insights into issues such as collapsibility, marginal and conditional effects and provide examples on how to use covariates to describe effects.

15 November 2022

Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings. Shiny is an R package that makes it easy to build interactive web apps straight from R.R u

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Vincent Shen, Ardalan Mirshani
Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings. Shiny is an R package that makes it easy to build interactive web apps straight from R.R u

14 November 2022

Starting in 2025, a system for HTA, not entirely unlike that of EMA for regulatory assessments, will apply to new medicinal products submitted for EMA regulatory review. The system will require manufacturers to submit an HTA evidence dossier broad enough to support each member state’s evaluation of relative effectiveness within the context of their specific healthcare system. Is this a ripple that will matter mostly for statisticians specializing in HTA – or is it a splash that should be on all pharmaceutical statisticians radar?

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Anders Gorst-Rasmussen, Anne Willemsen, Anja Schiel, Dima Samaha, Mihai Rotaru, Lara Wolfson.
Starting in 2025, a system for HTA, not entirely unlike that of EMA for regulatory assessments, will apply to new medicinal products submitted for EMA regulatory review. The system will require manufacturers to submit an HTA evidence dossier broad enough to support each member state’s evaluation of relative effectiveness within the context of their specific healthcare system.   Is this a ripple that will matter mostly for statisticians specializing in HTA – or is it a splash that should be on all pharmaceutical statisticians radar?

09 November 2022

Mark Baillie led the discussion on how to best visualise the impact and the pattern of missing values in EORTC QLQ-C30 questionnaire data. As an example a 2-arm phase III cancer trial was simulated with some data missing partly randomly, partly not. The visualisations are available on the Wonderful Wednesday blog.

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Mark Baillie led the discussion on how to best visualise the impact and the pattern of missing values in EORTC QLQ-C30 questionnaire data. As an example a 2-arm phase III cancer trial was simulated with some data missing partly randomly, partly not. The visualisations are available on the Wonderful Wednesday blog.

One display grouped the data by the amount of missing data in a line plot showing the relation to the outcome. Two different lasagna plots open the view to individual data of quality of live. The sorting is key to recognise patterns. With Sankey diagrams as small multiples the connection between age and missing data was displayed. The occurrence and frequency of different missing data patterns could be seen in an upset plot.  The next challenge is to display the COVID-19 vaccination adverse event 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, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, David Carr, Steve Mallett, Rhys Warham, Lovemore Gakava, Zara Sari, Paolo Eusebi, Greg Ball

 

08 November 2022

Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings. Shiny is an R package that makes it easy to build interactive web apps straight from R.

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Katrin Roth, Fiona Ehrich, Guiyuan Lei

Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings. Shiny is an R package that makes it easy to build interactive web apps straight from R.
The 3 presentations are titled; The dosedesignR – an interactive tool for planning dose finding studies, Adaptive Group Sequential Enrichment Designs App and An R Shiny App for Trial Diversity Dashboard. 

25 October 2022

Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings. Shiny is an R package that makes it easy to build interactive web apps straight from R.

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Ondrej Slama, Yilong Zhang, Monika Huhn.

Talks in these webinars will cover general frameworks for app development, regulatory submissions using R and case studies of using R Shiny in both operational and methodological settings. Shiny is an R package that makes it easy to build interactive web apps straight from R.

20 October 2022

This presentation provides a brief description of the herd protective effects of the oral cholera vaccines, as an example, that have been evaluated for herd protection in various study settings, leveraging the geographic information system (GIS) tools for analyses.

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Mohammad Ali
The population level effectiveness of a vaccine may arise as the result of direct protection of vaccinees and vaccine herd protection, which may protect non-vaccinees, vaccinees, or both. Indirect, total, enhanced, and overall vaccine protection are measures of vaccine herd protection. This presentation provides a brief description of the herd protective effects of the oral cholera vaccines, as an example, that have been evaluated for herd protection in various study settings, leveraging the geographic information system (GIS) tools for analyses. The study designs include individually randomized clinical trials, cluster randomized clinical trials, observational cohort studies, and observational case-control studies.

13 October 2022

Adaptive designs can offer more efficient trials for answering many questions of scientific interests. In this event we explored both cutting edge methodology for both the design and analysis of such designs. The speakers offered insight into the use of such methods in the pharmaceutical setting, sharing their experiences from designing such trials. We also heard personal views on adaptive designs.

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Sofia Villar (University of Cambridge), Frank Bretz (Novartis), Uli Burger (Roche), Carl-Fredrik (Caffe) Burman (AstraZeneca), Anh Nguyen (Roche), Haiyan Zheng (MRC Biostatistics Unit), Olivier Collingon (GSK) and Pantelis Vlachos (Cytel).

Adaptive designs can offer more efficient trials for answering many questions of scientific interests. In this event we explored both cutting edge methodology for both the design and analysis of such designs. The speakers offered insight into the use of such methods in the pharmaceutical setting, sharing their experiences from designing such trials. We also heard personal views on adaptive designs.

12 October 2022

Steve Mallet presents proposed solutions of how to visualise treatment effect on a range of scales of the EORTC QLQ-C30 questionnaire. As an example a 2-arm phase III cancer trial was simulated. And the visualisations are available on the Wonderful Wednesday blog.

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Steve Mallet presents proposed solutions of how to visualise treatment effect on a range of scales of the EORTC QLQ-C30 questionnaire. As an example a 2-arm phase III cancer trial was simulated. And the visualisations are available on the Wonderful Wednesday blog

The first plot combines patient level data and summary level data in one plot using different colors as well as alpha-blending for the individual data. A second proposal shows animated radio plots aka spiderweb plots with fading out historic values. Proposal number three is a dashboard with facet plots showing individual data side by side with summary statistics. This shows how the use color, blending, jittering and shading can help the interpretation of data. The next challenge is about the same data example, but some data points are missing. How can the different pattern of missing data be effectively visualized? 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, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, David Carr, Steve Mallett, Rhys Warham

04 October 2022

In this talk, we’ll outline six questions that help critically evaluate animal-based biomedical research from a therioepistemological perspective.

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Dr Brianna Gaskill

In recent years,  the scientific community has finally become more generally aware of the current reproducibility and translatability crisis. Some of this awareness has come from the recent NIH initiative on “Enhancing rigor, transparency, and translatability in animal research” starting a paradigm shift around certain themes. Colleagues and I feel that we are witnessing the birth of a new discipline, which we have termed Therioepistemology, or the study of how knowledge is gained from animal research. In this talk, I’ll outline six questions that help critically evaluate animal-based biomedical research from a therioepistemological perspective. Ultimately, by formalizing therioepistemology as a discipline, we can begin to discuss best practices that will improve the reproducibility and translatability of animal-based research, with concomitant benefits in terms of human health, animal well-being, and scientific quality.

14 September 2022

Health related quality of life as measured by the EQ-5D is dependent on a lot of different factors. How can the predictive value of certain patient characteristics be depicted? This Wonderful Wednesday is presented by Irene de la Torre Arenas. And the visualisations are available on the Wonderful Wednesday blog.

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Health related quality of life as measured by the EQ-5D is dependent on a lot of different factors. How can the predictive value of certain patient characteristics be depicted? This Wonderful Wednesday is presented by Irene de la Torre Arenas. And the visualisations are available on the Wonderful Wednesday blog

It helps to better understand the data, if the modelled dependency is plotted on top of the underlying data as done in the first proposal. The use of color helps to distinguish different dependencies. This can be further supported by plotting facets and choosing symbols, that can easily be identified. Another proposal showed the effects including interactions in a network plot and the relative importance side-by-side. The next challenge is about the different scales of a quality of life assessment in cancer patients. 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, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, David Carr, Steve Mallett, Julia Igel, Rhys Warham, Irene de la Torre Arenas

13 September 2022

If you've ever thought about making a career change or taking a career break then this Lunch & Learn can provide you with an insight from those who have been there and done it.

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Claire Brittain, Chetan Mistry, Lucy Rowell, Graeme Archer, Lucy Keeling.

The idea of changing careers or taking a career break can lead to feelings of being both frightened and excited at the same time. Our next PSI Lunch & Learn discussion will include a panel who have taken the leap and relaunched their careers. Find out about the benefits, the challenges and how it impacted their lives and careers in the long term.
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