In today’s episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be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!
In this episode, Paolo and I discuss the importance of visualisation in understanding subgroups.
We touch on a number of interesting topics during the interview, including how Altmetric and Dimensions work together in uncovering this journey, but also the insights that can be gleaned from the kind of data the tools provide.
In today’s episode, Rachel and I will discuss the things that we would like to have known before we started working with RWE so stay tuned to avoid mistakes we made in the past.
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