This year we are delighted to offer two pre-conference courses, set to run on Sunday 8 June from 1pm - 5pm. They will be held at the Novotel London Wembley.
Pre-conference Course 1
Unlocking Insights: Advanced Pooled Analyses Techniques for Clinical Trial Statisticians
Course description: This course provides a comprehensive introduction to pooled analyses of randomized controlled trial (RCT) data, with a focus on methodologies and applications essential
for clinical trial statisticians. Pooled analyses provide significant benefits during various stages of drug development, and may help to examine subgroup effects, analyse rare (e.g., adverse) events, and estimate more individualized treatment effects.
We will cover statistical techniques for analysing individual participant data (IPD) from multiple trials, with a particular focus on meta-analysis methods that address potential heterogeneity between study populations. To ground these concepts, the
course will include applied case studies that demonstrate how IPD meta-analyses enhance the precision and applicability of findings, ultimately supporting more personalized and impactful analyses in clinical research. This course equips statisticians
with the expertise to apply advanced meta-analysis techniques to real-world clinical trial data, strengthening their ability to conduct rigorous and meaningful analyses that inform evidence-based decision-making.
Organisers:
• Dr. Thomas Debray, Smart Data Analytics and Statistics B.V., The Netherlands
Thomas Debray, PhD is a distinguished statistician and academic who transitioned from academia into specialized consulting for the pharmaceutical industry, leveraging his expertise in real-world evidence (RWE), precision medicine, and evidence synthesis
to drive innovation in clinical research. Thomas is the author of various methodological guidelines, including TRIPOD-Cluster, which enhances reporting standards for prediction models developed in pooled analyses and datasets with clustering. He also
contributed to the latest ENCePP Methodological Guide, focusing on statistical methods to generate evidence for comparative effectiveness research from randomised clinical trials (RCTs), observational data, synthesis of published RCTs and cross-design
synthesis.
As the founder of Smart Data Analysis and Statistics (SDAS), Thomas leads a team dedicated to advancing clinical trial methodologies and providing tailored statistical support to pharmaceutical companies and biotech firms. Under his
leadership, SDAS has developed various analytical tools, including SimTOST, a comprehensive R package designed to optimize the design of bioequivalence trials with multiple treatment arms and (co-)primary endpoints. SDAS is also a trusted partner
in pioneering academic research projects, such as the Marie Curie SHARE-CTD project, where it trains early-career researchers in advanced methodologies for analysing data across multiple clinical trials.
• Prof. Tim Friede, University Medical Center Göttingen, Germany
Tim Friede has served as Professor of Biostatistics at the University Medical Center Göttingen since January 2010, where he leads the Department of Medical Statistics. He holds a degree in Mathematics (Dipl.-Math.) from the University of Karlsruhe
and a Ph.D. (Dr.sc.hum.) from the Faculty of Medicine at the University of Heidelberg.
In 2001, he began his career in academia as an NHS Training Fellow in Medical Statistics in the Department of Mathematics and Statistics at Lancaster University,
where he was later promoted to Lecturer in Biostatistics. In 2004, he joined Novartis Pharma AG in Basel before transitioning to Warwick Medical School as an Associate Professor of Medical Statistics in October 2006.
In 2014, he earned the “Biometry
in Medicine” certificate from the German Society for Medical Informatics, Biometry, and Epidemiology (GMDS) and the German Region of the International Biometric Society (IBS-DR), solidifying his credentials as a trial statistician.
Tim
has been a member of the Sino-German Institute for Social Computing (SGISC) since 2015 and joined the SGISC Board of Directors in early 2020. Additionally, he became a member of the Campus Institute Data Science (CIDAS) in 2023.
Pre-conference Course 2
Adaptive and Complex Innovative Designs across trial phases for accelerated approval
Course description: Recently gave a course at the ASA Regulatory-Industry Statistics workshop that we would like to propose as an option for PSI. The course involves interactive discussions
of case studies of real-life clinical trials, with a focus on the statistical and practical considerations around the chosen study design
Our aim is to give a minimally theoretical overview of a wide range of innovative adaptations available for trial designs, with a focus on how these methods are being implemented in real-life trials and how such methods fit into the regulatory initiatives.
For each concept, we will describe the study design, the practical benefits for which this was selected, the statistical considerations that are required for a robust interpretation of results around hypothesis testing and estimation, and discussions
of funding, preserving integrity and reporting results at study completion.
We would present and share a 'Start Here' beginners' guide for adaptive designs, which collates a range of practical resources including papers and tutorials to simplify
the use of adaptive designs in practice.
Organisers:
- Dr. Thomas Burnett, Lecturer, Department of Mathematical Sciences Bath Institute for the Augmented Human Institute for Mathematical Innovation (IMI)
- Dr. Ayon Mukherjee, C.Stat, Director Statistical Methodologist, Merck
- Dr. David Robertson, Senior Research Associate at the MRC Biostatistics Unit, University of Cambridge
- Dr Sofia Villar, MRC Investigator (Programme Leader)
Course Fees
The registration fees for the pre-conference courses are as follows:
Registration Item | Early Bird Rate | Standard Rate |
---|
PSI Member | £210.00 | £250.00 |
Non member | £280.00 | £325.00 |
The number of places on these courses is limited, register today! You can register here:
Register Now