Video-on-Demand Library


Collection
Keyword or phrase

Topic

PSI VisSIG Wonderful Wednesday 51: Platform trial design I

12 June 2024

How can visualisations help better understandtrial design? Steve Mallet is explaining some ideas based on simulations for a platform trial. The visualisations are available on the Wonderful Wednesday blog.

Read more...

How can visualisations help better understandtrial design? Steve Mallet is explaining some ideas based on simulations for a platform trial. The visualisations are available on the Wonderful Wednesday blog.

Visualisations can give a quick overview over a vast amount of design options. This can be achieved with facet plots, with interactive plots allowing to switch between the options, or even combing facets with interactivity as show in a shiny app. Also the use of different colours and line types can increase the number of displayed scenarios. For the next challenge we will look at the same data aiming to visualise three very specific aspects. 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, Zachary Skrivanek, Lorenz Uhlmann, Steve Mallett, Rhys Warham, Mark Baillie, Paolo Eusebi, Martin Brown


Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium

06 June 2024

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you. Regulatory and Analytical experts will share the overview of their involvement and their insights when working with Mobilise D consortium

Read more...

Daniel Rooks, Igor Knezevic, Wim Dartee, Arne Mueller, Julia Chernova

We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you. Regulatory and Analytical experts will share the overview of their involvement and their insights when working with Mobilise D consortium.

PSI Webinar: Surrogacy

29 May 2024

This webinar starts with providing an overview of surrogacy for licensing and reimbursement. This articulates the need of extensions of the SPIRIT and CONSORT statement related to surrogacy...

Read more...

Oriana Ciani (SDA Bocconi School of Management), Rod Taylor (University of Glasgow; University of South Denmark), Anthony Manyara (Bristol university; University of Glasgow), Ray Harris (Retired), Mario Ouwens (AstraZeneca).

This webinar starts with providing an overview of surrogacy for licensing and reimbursement. This articulates the need of extensions of the SPIRIT and CONSORT statement related to surrogacy. Both the process to define the extensions as well as the extensions themselves are then presented. The importance of right communication of the interpretation of surrogate outcomes to patients is articulated by a patient representative. Finally, it is shown by results from a simulation study that maturity influences the probability of success of surrogacy validation, among other factors like variation in estimated treatment effects.

PSI Webinar: Drug Development in Women’s Health

15 May 2024

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about analysing the menstrual cycles, a novel mathematical approach to designing IVF needles and statistical challenges when planning IVF studies.

Read more...

Elizabeth Garner (Ferring Pharmaceuticals US), Christoph Gerlinger (Bayer), Radu Cimpeanu (University of Warwick), Jack Wilkinson (Manchester University).

This multidisciplinary webinar will cover the latest insights in women's health. Clinicians, applied mathematicians and statisticians will provide valuable perspectives on current challenges and opportunities in the field covering recent developments in women’s health drug development, statistical complexities of in vitro fertilization (IVF) and insights into the statistical considerations surround the menstrual cycle and menstrual bleeding measurements. 
● Opening on drug development in women’s health - Elizabeth Garner (Ferring Pharmaceuticals US)
● Menstrual cycle and Measurement of menstrual bleeding - Christoph Gerlinger (Bayer AG)
● A new flow-based design for double-lumen needles in IVF - Radu Cimpeanu (University of Warwick)
● Challenges in RCTs of in vitro fertilisation : an estimands perspective - Jack Wilkinson (Manchester University).

The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about analysing the menstrual cycles, a novel mathematical approach to designing IVF needles and statistical challenges when planning IVF studies.

PSI VisSIG Wonderful Wednesday 50: Study flow charts

08 May 2024

In almost every study there is a flow chart to present the patient's path through the trial. What could the next level of study flow charts look like? Zak Skrivanek is presenting some new ideas. And the visualisations are available on the Wonderful Wednesday blog.

Read more...

In almost every study there is a flow chart to present the patient's path through the trial. What could the next level of study flow charts look like? Zak Skrivanek is presenting some new ideas. And the visualisations are available on the Wonderful Wednesday blog.

Sandard study flow charts are basically organised lookup tables. A true visualisation can do much more. For example colour coding or indenting boxes can help organising. Also additional information can be embedded. This can easily done in R. For patient disposition Sankey diagrams can be extremely useful. This is even more powerful if used interactively. People charts even go without explanation. 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, Zachary Skrivanek, Lorenz Uhlmann, Steve Mallett, Rhys Warham, Mark Baillie, Paolo Eusebi, Martin Karpefors


Joint PSI/EFSPI Vaccine SIG Webinar: Statistical and Mechanistic Models for Correlates of Protection

25 April 2024

This webinar will explore two different approaches to Correlates of Protection in vaccine development. Statistical models providing a quantitative framework for identification and validation of potential CoPs, and mechanistic models aiming to understand the biological mechanisms driving immune responses and protection.

Read more...

Dr. Erin Gabriel and Dr. Melanie Prague.

This webinar will explore two different approaches to Correlates of Protection in vaccine development. Statistical models providing a quantitative framework for identification and validation of potential CoPs, and mechanistic models aiming to understand the biological mechanisms driving immune responses and protection. By integrating these two approaches, researchers can gain better insights into the immunological factors associated with vaccine efficacy and infection protection. This webinar will include talks from two renowned speakers who will discuss the principles, applications, and challenges of both statistical and mechanistic models, contributing to a better understanding of CoPs and optimizing vaccine clinical trial design.

PSI Webinar: Open Source Software - is it really a free-for-all?

17 April 2024

Talks from the speakers will cover the use of R in a programming community, submitted to regulators using R, and also programming beyond R in C++ and Julia.

Read more...

Matthew Lyon, Ari Siggaard Knoph, Daniel Sabanes-Bove

Talks from the speakers will cover the use of R in a programming community, submitted to regulators using R, and also programming beyond R in C++ and Julia.

Slides
You can download Matthew's slides and Ari's slides from the 'documents' section below, and you can access Daniel's slides here.

PSI webinar: Navigating HTA and Patient Access with Insights from Indirect Treatment Comparisons

11 April 2024

The speakers cover an introduction to HTA and indirect comparisons for value assessment before focusing more specifically on topics related to the use of indirect treatment comparisons for patient access.

Read more...

Lara J Wolfson, Jenny Devenport, Alex Simpson, Christian Röver

The speakers cover an introduction to HTA and indirect comparisons for value assessment before focusing more specifically on topics related to the use of indirect treatment comparisons for patient access.

PSI VisSIG Wonderful Wednesday 49: Explain Power

10 April 2024

Sample size and power calculations are an important task for statisticians at the planning stage of a trial. Steve Mallet presents powerful visualisations to explain the impact of change in assumptions to a "non-technical" audience. Visualisations are available on the Wonderful Wednesday blog.

Read more...

Sample size and power calculations are an important task for statisticians at the planning stage of a trial. Steve Mallet presents powerful visualisations to explain the impact of change in assumptions to a "non-technical" audience. Visualisations are available on the Wonderful Wednesday blog.

A small shiny app is helping to explain the concept of type I and type II errors. Depending on the actual question Statulator plots, trellis plots or even 3D plots can be used to support the argumentation. This concept casn also be used for Bayesian methods. The next challenge is on study flow charts. 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, David Carr, Steve Mallett, Rhys Warham, Lovemore Gakava, Zara Sari, Paolo Eusebi, Martin Karpefors.


PSI Journal Club: Limitations and Challenges with Mixed Model Repeated Measures (MMRM) Analysis

09 April 2024

Moses Mwangi and Florian Lasch present their recent work with discussion lead by Geert Molenberghs.

Read more...

Presenters: Moses Mwangi and Florian LaschChair: Geert Molenberghs

Moses Mwangi and Florian Lasch present their recent work with discussion lead by Geert Molenberghs. 

Joint PSI/EFSPI Pre-Clinical SIG Webinar: OMARS Designs: Factor Screening and Response Surface Optimization in a Single Step

26 March 2024

A technical feature of the initial OMARS designs is that they study every quantitative factor at its middle level the same number of times. In this talk, we relax this constraint and arrange the designs in blocks, and thereby broaden the family of OMARS designs, presenting application of OMARS designs in pharmaceutical and chemical industries.

Read more...

Peter Goos

The family of orthogonal minimally aliased response surface designs or OMARS designs bridges the gap between small definitive screening designs and classical response surface designs, such as central composite and Box-Behnken designs. The initial OMARS designs involve three levels per factor and large numbers of quantitative factors to be studied efficiently using limited numbers of experimental tests. Many of the OMARS design possess good projection properties and offer better powers for quadratic effects than definitive screening designs with similar numbers of runs. Therefore, OMARS designs offer the possibility to perform a screening experiment and a response surface experiment in a single step, and thereby offer the opportunity to speed up innovation and process improvement. A technical feature of the initial OMARS designs is that they study every quantitative factor at its middle level the same number of times. In this talk, we relax this constraint and arrange the designs in blocks, and thereby broaden the family of OMARS designs, presenting application of OMARS designs in pharmaceutical and chemical industries. 

Joint PSI/EFSPI HTA SIG Webinar: Indirect treatment comparisons - choosing the right tool for the job (Part 2)

18 March 2024

The speakers will review and compare different approaches for ITC in both anchored and unanchored case. Both drug regulatory and reimbursement body’s views on using ITC will be discussed. The speakers will offer insights into issues such as marginal and conditional effect, unmeasured confounding and provide case studies to demonstrate the use of ITC methods in practice.

Read more...

Min-Hua Jen, Kate Ren, Andrew Thomson, Marcia Rueckbeil and Richard Sizelove

Randomised controlled trials (RCTs) have been the gold standard for the evaluation of efficacy and safety of medical interventions. However, investigators have incentives to look for alternative ways to obtain relevant comparative effect estimates more rapidly for healthcare decision makers. The EUnetHTA 21 methodological guidelines will be officially finalised late in 2024 and will impact the statistical approaches used to obtain these effect estimates. Indirect treatment comparisons (ITCs) for the joint clinical assessment (JCA) require the estimation of comparative effectiveness via non-randomised designs.    Statisticians must be prepared for the changes this guidance will require. Indirect treatment comparisons should be considered a fundamental tool in the pharmaceutical statistician's toolbox, alongside other commonly used statistical techniques in the industry.  This webinar aims to provide information on the purpose and methods for ITC. The speakers will review and compare different approaches for ITC in both anchored and unanchored case. Both drug regulatory and reimbursement body’s views on using ITC will be discussed. The speakers will offer insights into issues such as marginal and conditional effect, unmeasured confounding and provide case studies to demonstrate the use of ITC methods in practice.  The event will be structured as two webinars, each of 3 hours. The first webinar will discuss ITC for an anchored case. The second webinar will discuss ITC for an unanchored case. You do not have to attend both webinars, but we highly recommend you join both webinars to have a comprehensive understand of the topic in ITC.  
Page:

Upcoming Events

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

PSI EIWG Webinar: Estimands framework in action, the Alzheimer's disease case

The webinar will show how the estimand framework was applied in a Phase 3 trial in Alzheimer's disease.

PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations

This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.

PSI Career Young Virtual Event (Q3 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

PSI Training Course: Regulatory Guidelines for Statisticians

This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.

Joint PSI/EFSPI Causal Inference SIG Webinar: Opportunities in applying a causal inference framework during the analysis of an RCT

This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.

Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies

Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.

PSI Career Young Virtual Event (Q4 2024)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Apprentice Statistician

This apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.

Statistician, Data Science

We have exciting new opportunities available for Study Statisticians, Support Statisticians and Exploratory Statisticians at various levels.