What is extrapolation?
How can we use extrapolation in paediatrics?
What are the main challenges?
Paediatric research always comes with challenges, and understanding paediatric submission is vital. There’s always a lack of treatment in this area. In this episode, you’ll understand what you can do to get evidence through extrapolation for the children’s population.
Stay tuned while Andrew and I talk about the following:
- What is extrapolation?
- What are the source and target populations?
- The guidance states: “Where possible, quantitative methods should be used for the collation of available data and the investigation of potential modifiers of the treatment effect”. How could such quantitative methods look like?
- What are the major challenges?
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Andrew Thomson
He is a statistician at the EMA Taskforce dedicated to Data, Analytics and Methodology, joining the Agency in 2014. He supports the methodological aspects of the assessments of Marketing Authorization Applications, as well as Scientific Advice, and methodological aspects of Paediatric Investigational Plans. Additionally, he is the EC lead for ICH E11A where he leads the statistical work stream.
Before the EMA, he worked at the UK regulator, the Medicines and Healthcare product Regulatory Agency. Here he worked initially as a statistical assessor in the Licensing Division, assessing Marketing Application Authorizations and providing Scientific Advice to companies. After rising to Senior Statistical Assessor, he moved to the Vigilance and Risk Management of Medicines Division, to be Head of Epidemiology. Here he managed a team of statisticians, epidemiologists and data analysts providing support to the assessment of post-licensing observational studies and meta-analyses. He also managed the team’s design, conduct and analysis of epidemiology studies, using the UK Clinical Practice Research Data link.
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