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.
Boosting clinical trial data with external data belongs to the very hot topics at the moment. Every conference includes a session about it and many webinars present about it. I’m very happy to have an expert in this area on the show – Gaëlle Saint-Hilary. Learn, when is it appropriate to use historical data and when is it appropriate to enrol new patients to collect new data.
This is a special episode while Benjamin and I talk about the upcoming PSI conference and what you can expect from it. This will be a face to face conference in Gothenburg, Sweden!
In today’s episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be considered when developing COA-based endpoints.
In today’s episode, Dr. Stefan Walzer and I discussed the goal of the Digital Health Application.
In today’s episode, Antoine and I answer these questions and more. E.g. we talk about the importance of calibrating the relevance of the existing items in the questionnaire and developing new ones in order to reach more accurate measurements resulting in good PROs.
What is medical affairs? Launch and Lifecycle?
How has this area evolved over the last 2 decades?
What is the current state across the industry in terms of the role of statistics in this space?
This is a series of episodes and today’s content is the first episode.
When there is one topic, which is really hot, it’s causal inference. I’ve got in contact with it about 20 years ago when analysing observational studies and when nobody working on clinical trials would consider it. But now – after the introduction of the estimands framework – this becomes part of every statisticians toolkit. Today, we have one of the world leading experts in this field as a guest – Miguel Hernan.
The guest in this episode represents the sponsor of this show – Nigel Howitt – current chair of PSI.
In this episode, Liane Davey, who is the author of the book “The Good Fight”, and I will be discussing about how to say no effectively. I met her on LinkedIn and we had a couple of messages and it was just really cool that we think the same way. Stay tuned because you’ll surely love it!
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