Interview with Andrew Thomson What is extrapolation?How can we use extrapolation in paedriatics?What are the main challenges? Paedriatic research always comes with challenges and understanding paedriatic submission is very important. There's always a lack of treatment in …
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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 …
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A preview into the PSI conference
Why are we raving about this conference?Why is this the best conference I have been attending?What are the other activities beside the scientific part of the conference? This is a special episode while Benjamin and I talk about the upcoming PSI conference and what you can …
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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 …
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