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01 December 2020

The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic.

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Jenny Thomas, Chris Smith, Alice Hedge
The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic. For electrocardiography and jacketed external telemetry data, it will discuss scientific preferences, historical data review and statistical recommendations. For Developmental and Reproductive Toxicology endpoints, it will focus on neurobehavioral data. In these studies, the actual impact of sex on a given endpoint can be very much dependent on the age of the animals being tested. It is widely considered by scientists that very young animals may not demonstrate any differences due to sex. However, these tests are conducted at various stages in development so a statistical plan that accounts for potential sex differences, whilst still allowing for the additional power that may be observed from pooling the sexes is required.

25 November 2020

In this video/Webinar focus is given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way are discussed.

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Graham Healey and Dea Putri
The deployment of biomarkers in drug development and diagnostics has many challenges ranging from analytical validation, in vivo study design, to the translation to human utility and financial considerations. In this video/Webinar focus is given to safety biomarkers. Statistical issues in data science that nonclinical statisticians might encounter along the way are discussed.

17 November 2020

Watch this Journal Club webinar to hear Jingjing Ye (BeiGene) and Amy LaLonde (Eli Lilly) present their recent work. The webinar will be chaired by Bruno Boulanger (PharmaLex).

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Jingjing Ye (BeiGene):- A Bayesian approach in design and analysis of pediatric cancer clinical trials
Authors: Jingjing Ye, Gregory Reaman, R. Angelo De Claro & Rajeshwari Sridhara
Pharmaceutical Statistics. 2020;1–13.


Amy LaLonde (Eli Lilly):- Estimation of group means using Bayesian generalized linear mixed models
Authors: Amy LaLonde & Yongming Qu
Pharmaceutical Statistics. 2020;19:482–491

11 November 2020

Zachary Skrivanek guides through a number of data visualisations explaining a mediated treatment effect on patient reported quality of life. In addition the problem of missing data should be handled within the graphical representation.

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Zachary Skrivanek guides through a number of data visualisations explaining a mediated treatment effect on patient reported quality of life. In addition the problem of missing data should be handled within the graphical representation.

A Lollipop plot and a bar chart were presented as well as multiplot solutions using correlation plots or a combination of scatter plots, modelling plots and distribution plots. A point of discussion was the usability of a parallel coordinates plot. Another proposal used a Bayesian model displaying the results in an impressive grable – a combination of graphic and table. The last approach used an innovative way of storytelling with data called scrollytelling. The new challenge was introduced and will be about visualisation of the meta-analysis example.

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.

05 November 2020

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 Estimands in Practice. Speakers from regulatory authorities (FDA and EMA) and industry will present on their experience on the recent ICH E9 (R1) guidance.

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John Scott, Andreas Brandt, Evgeny Degtyarev and Vladimir Dragalin.

The following aspects are covered:
- Experience with proposals submitted to FDA and EMA on implementation of Estimands
- How the estimands framework facilitates interaction with clinicians in different therapeutic areas
- Common problems where the Estimands framework can help advance research
- Where further discussions and research is required, and particularly where industry and regulators can collaborate
- Issues related to alignment between different estimators to a given estimand
- Special considerations of estimand framework in COVID-19 vaccine trials.

15 October 2020

Dr. Dean Follmann and Dr. Frank Harrell

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The Vaccine SIG is proud to bring you this webinar, which features two presentations on topics relating to methodological developments in vaccines research. We are delighted to be joined by Frank Harrell who will present 'Sequential Bayesian Designs for Rapid Learning in COVID-19 Therapeutic Trials'; and also by Dean Follmann, who will present on 'Statistical Aspects of COVID-19 Vaccine Trials'.

14 October 2020

Abi Williams presented data visualisations on co-occurrence of adverse events. How to display events that occur at the same time in the same patient and highlight differences of treatment or gender? A variety of very different approaches was discussed.

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Abi Williams presented data visualisations on co-occurrence of adverse events. How to display events that occur at the same time in the same patient and highlight differences of treatment or gender? A variety of very different approaches was discussed.

The first visualisation was a heatmap for the frequency of co-occurrences. A Lollipop plot combined the frequency with the overlap time. Then a Shiny App made interactive exploration of up to 4 co-occurring events possible. The presentation of an UpSet plot brought up a discussion on the advantages over the vinn diagram. The shiny app AdEPro was referred to as an useful exploration tool for adverse event in general. Another tool for exploring the co-occurrence in particular was the force directed network graph. The final approach was embedded in a PowerBI Dashboard. The new challenge was introduced and will be about visualisation of the mediation data example.

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.

 

13 October 2020

Sheila Dickinson, Rachael DiSantoStefano, Gaelle Saint-Hilary

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Patient preference studies are becoming more frequently used in drug development. In this webinar you will hear an introduction to what a patient preference study is as well as an overview of where this type of study can inform regulatory decision making. This will be followed by 2 examples looking at potential approaches to eliciting patient preference demonstrating how such studies can be designed and analysed.

23 September 2020

Hans-Joachim Helms, Andrew Thomson, Martin Posch and Kristine Broglio

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A protocol of a clinical trial with a design that allows testing multiple drugs and/or multiple sub-populations in parallel, is called master protocol. Master protocols have been used in the pharmaceutical industry for some time now and examples include the I-SPY 2 trial and the Lung-MAP trial.
For this webinar, PSI brought together experts on master protocols from the pharmaceutical industry, academia, and regulatory agencies. The speakers recapitulated terminology surrounding master protocols, presented recent advances in the methodological research on master protocols, discussed concerns regarding type I error control and Bayesian approaches, and outlined the operational aspects of running a clinical trial with a master protocol through case studies.

16 September 2020

Watch this Journal Club webinar on “Longitudinal Data”. Florian Lasch (Hannover Medical School, Germany) and Mutamba Kayembe (Maastricht University, Netherlands) presented their recent work. The webinar was chaired by Michael O’Kelly (IQVIA).

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Florian Lasch (Hannover Medical School, Germany):- Empirical evaluation of the implementation of the EMA guideline on missing data in confirmatory clinical trials: Specification of mixed models for longitudinal data in study protocols
Authors: Sebastian Häckl, Armin Koch & Florian Lasch
Pharmaceutical Statistics, 2019; volume 18, Issue 6, Pages 636-644.
Access the slides here.

Mutamba Kayembe (Maastricht University, Netherlands):- Imputation of missing covariate in randomized controlled trials with a continuous outcome: Scoping review and new results
Author: Mutamba T. Kayembe, Shahab Jolani, Frans E. S. Tan & Gerard J. P. van Breukelen
Pharmaceutical Statistics. Early view. 
Access the slides here.

09 September 2020

Alexander Schacht, Mark Baillie, Daniel Saure, Bodo Kirsch, Zachary Skrivanek, Lorenz Uhlmann, Rachel Phillips, Markus Vogler, David Carr, Steve Mallett, Abi Williams and Mike Greenwood.

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How to display safety data? This month's challenge has shown there are very different ways to visualize adverse event data. Although the example data set was from a two-arm study and relatively simple, the display of type of AE, frequency, timing, severity and seriousness is not easily combined in one plot.

03 September 2020

Caroline Caudan, Paulo Eusebi & Michael O'Kelly

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This webinar features presentations from 3 speakers on the topic of Using Visualisations to Help Make Decisions: Caroline Caudan presents ‘Interactive statistical monitoring to optimize review of potential study issue with R-Shiny’, Paolo Eusebi presents ‘Effective visualization of uncertainty – Where we are and where to go’ and Michael O’Kelly presents ‘Subgroup analysis: a look at the SEAMOS approach (Standardised Effects Adjusted for Multiple Overlapping Subgroups)’. These presentations were originally planned as part of the 2020 PSI conference in Barcelona, and have been reorganised as a webinar.
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