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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.

12 August 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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In this month’s webinar, we discussed an exacerbation example data set. The data is based on the RISE study for patients with moderate COPD. The primary endpoint is the number of exacerbations during a six month treatment period. Event data – but patients can (and do) have multiple exacerbations. Statistical analysis used a Negative Binomial model. The dataset also included other variables which (may) effect the exacerbation rate: % Predicted Normal of Forced Expiratory Volume in 1 second (FEV1), Exacerbations in previous year, and Region / Gender.

The challenge was to produce a data visualisation incorporating the information on the number of exacerbations observed. The discussed visualisations included a straightforward and clear presentation of the number of exacerbations, a Power BI app, longitudinal plots, and a display of patient-level outcomes.

15 July 2020

Bruno Boulanger

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4 key learnings attendees will take away from this webinar:
- The value of good design of experiments
- Consider Bayesian statistics to answer your question
- P-values is not always what you’re looking for
- Adopt a life-cycle over the long-run, not just study by study.

For 15 years the scientific literature has repeatedly underlined the important lack of reproducibility and replicability of studies in biomedical research. As a consequence, several scientific organisations (journal, scientific societies, universities, national agencies) have identified some root causes to this issue and proposed good research practices to improve the replicability of the results. The misuse of statistical concepts, from design of studies to analysis of data to decision-making is at the heart of the crisis, even if not the only cause. In this webinar we will explain the how to understand the sequences of issues and how to fix it in order to drastically improve the replicability of the results. Through example the presentation will cover concepts such as OFAT vs DoE, p-values and Bayesian statistics and Power vs Assurance as easy opportunities to improve robustness of decisions.

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