What are biomarkers, and why is this essential?

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 Beyonce gets a mention too!

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 this area. In this episode, you'll understand what you can do to get evidence through extrapolation for the children population.

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?

I know you've had this dilemma of either having had the difficulty in collecting data or having too much available and yet irrelevant data while trying to conduct a clinical trial. When is it appropriate to use historical data and when is it appropriate to enroll new patients to collect new data?

Today, Gaëlle and I talked about the main objective of using historical data in clinical trials.

Why are we raving about this conference?
Why is this the best conference I have been attending to?
What are the other activities beside the conference itself?

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!

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In today's episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be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.

What is a DIGA?
Why is Germany so important for DIGAs?

Nowadays, there are a couple of available apps being used in several countries that collect user information, such as heart rate combined with algorithms that calculate certain health risks that the user may be vulnerable to. What differentiates these apps from the apps listed in the DIGA registry?

In today's episode, Dr. Stefan Walzer and I discussed the goal of the Digital Health Application.

Why do companies want to develop new patient-reported outcomes?
How does the process start when we want to develop a new questionnaire?
What are the key areas to look into for understanding the quality of a PRO?
What guidelines exist for developing new PROs?

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?

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. I'm talking with him about:

How can this help generate and analyze data to identify better strategies for the treatment and prevention of both infectious and noninfectious diseases?