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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...

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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.

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.

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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.

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.

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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


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.

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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.

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.

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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.

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.

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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.

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.

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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.


09 April 2024

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

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Presenters: Moses Mwangi and Florian LaschChair: Geert Molenberghs

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

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.

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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. 

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.

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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.  

13 March 2024

This Wonderful Wednesday was created in collaboration with the Biomarkers SIG. Rhys Warham is presenting the proposed plots. Visualisations are available on the Wonderful Wednesday blog.

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This Wonderful Wednesday was created in collaboration with the Biomarkers SIG. Rhys Warham is presenting the proposed plots. Visualisations are available on the Wonderful Wednesday blog.

Special guests Mathilde Saccareau and Guillaume Desachy are joining the panel to discuss pros and cons of different visualisations. To be displayed is data of vaginal microbiom profiles over time comparing pre-term birth and term birth. Proposed were donut charts and raincloud charts as well as specific T-SNE and UMAP plots, The next challenge is an open challenge on displaying sample size and power calculations to a "non-technical" audience. 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

26 February 2024

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.

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Min-Hua Jen, Antonio Remiro-Azocar, Anja Schiel, Suzy Van Sanden

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. 

Day 1, 26th February 2024: Indirect treatment comparison for anchored setting

  • Antonio Remiro-Azocar (Bayer) - Marginal versus conditional estimands, non-collapsibility and standardization in the context of indirect treatment comparisons
  • Anja Schiel (Norwegian Medical Products Agency (NoMA) - ITC’s applicability and acceptability in the European HTA landscape
  • Suzy Van Sanden (Johnson & Johnson) - Matching-adjusted indirect comparison (MAIC): A case studies in prostate cancer
  • Panel discussion
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