Chats with Jenn: Embracing Vulnerability and Leading with Courage
Today’s episode is an extract from my interview with Jenn Fenwick, who’s also a podcaster like me and we talk about my career and leadership.
Podcast
Extrapolation to Paediatrics
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.
How to Integrate External Data into Your Clinical Studies: From Theory to Application
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.
A Preview into the PSI Conference
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!
Patient-reported Outcomes and the FDA Patient-Focused Drug Development Guidance
In today’s episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be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.
Apps on Prescription Paid by the Government
In today’s episode, Dr. Stefan Walzer and I discussed the goal of the Digital Health Application.
What Does It Take to Develop Good Patient-Reported Outcomes?
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 the Current State of Launch and Lifecycle Work and How Did It Evolve?
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.
The Best of Causal Inference
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.
Replay of How To Get The Most Out from Your PSI Membership
The guest in this episode represents the sponsor of this show – Nigel Howitt – current chair of PSI.
