Month: May 2022

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. This is a fun chat where we talk about navigating fear, opening ourselves up to vulnerability and making courageous decisions… oh and Beyoncé gets a mention too!   This is …

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Extrapolation to paediatrics

Interview with Andrew Thomson 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 …

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How to integrate external data into your clinical studies: from theory to application

Interview with Gaëlle Saint-Hilary What are the benefits of including external data in the design and analysis of clinical studies?How does the meta-analytic predictive model (MAP) work? 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 …

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Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance

Interview with Rachael Lawrance The FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making. In today’s episode, we discuss …

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