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19 January 2023

In this webinar, you will hear an introduction on biomarkers and learn more about recent advances in biomarker-based designs, machine learning for biomarkers and data repositories for biomarker use cases.

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In this webinar, you will hear an introduction on biomarkers and learn more about recent advances in biomarker-based designs, machine learning for biomarkers and data repositories for biomarker use cases. 

The webinar starts with an introduction of the Biomarkers Special Interest Group and a whistle-stop tour on biomarkers.

Presentation 1: Enrichment designs with predictive biomarkers
Most biomarker-driven trial designs are based on the assumption that the biomarker is predictive of response to treatment.
Would you rather verify this assumption during the trial?
If so, which population and subpopulations would you test?
What regulatory issues might you encounter?
How would you setup your hypotheses?

At the PSI Biomarkers SIG, we are addressing these issues within the setting of adaptive enrichment designs for Phase II trials in oncology.

Presentation 2: Who said Machine Learning for Biomarkers?
What do you expect from an inspiring  presentation on Machine Learning for Biomarkers? 
1. Excitement, because you have learned about all the sophisticated Machine Learning methods out there?
2. Being impressed by success stories on Machine Learning & biomarkers?
3. Actionable guidance so that you can incorporate Machine Learning for Biomarkers into your own work?
We, the PSI Biomarkers SIG, want to give it a try and share our thoughts on the past, present and future of Machine Learning for Biomarkers with you.

Presentation 3: But where is the data?

You've discovered this cool new Machine Learning technique but have no data to try it on?
Or you have heard of a new groundbreaking kind of biomarkers?
Or you are like: it is time for me to get my hands dirty with RNA-seq data!

We’ve all been in such situations but then comes the harsh reality: finding publicly available biomarkers data is hard. Finding publicly available biomarkers data along with corresponding treatment response is even harder. 
Changing this was the motivation of the PSI Biomarkers SIG to have a focus on data repositories. 
During this presentation, we will share with you the fruit of this work! 

11 January 2023

We're looking back to Wonderful Wednesday Webinars of 2022. What graphical displays stood out and what made them special? The visualisations are available on the Wonderful Wednesday blog.

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We're looking back to Wonderful Wednesday Webinars of 2022. What graphical displays stood out and what made them special? The visualisations are available on the Wonderful Wednesday blog

In 2022 a lot of impressive visualisations have been submitted to solve very different challenges. The best ones are being revisited in this webinar to highlight how visual displays can be used most effectively. The next webinar will address the visualisation of estimands. 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

14 December 2022

Visualising rich adverse event data can be problematic. The Vaccine Adverse Event Reporting System (VAERS) is an example of such data that is discussed in this webinar. The visualisations are available on the Wonderful Wednesday blog.

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Visualising rich adverse event data can be problematic. The Vaccine Adverse Event Reporting System (VAERS) is an example of such data that is discussed in this webinar. The visualisations are available on the Wonderful Wednesday blog

As a start the Open VAERS visualisation is examined. Another display is the dashboard on public tableau with additional features like filtering. For adverse event data of clinical studies comprehensive visualisation apps as SafetyGraphics and DetectoR enable exploration and presentation of incidences and treatment differences. The next webinar will be used to select the best visualisations of 2022. 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.

07 December 2022

An introduction to the event from the chairs of PSI and PSI CALC, followed by the New Starter Presentation and a Panel Discussion featuring company volunteers.

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An introduction to the event from the chairs of PSI and PSI CALC, followed by the New Starter Presentation and a Panel Discussion featuring company volunteers.
Chrissie Fletcher, Amanda Darekar, Eleanor Van Vogt, Emma Crawford, Lauren Desoya, Ben Webb, Yolanda Barbachano, William Holmes, Lydia Buckley.

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.
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