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In today's episode, we discuss the process with the FDA publishing a timeline of planned public workshops, draft guidance documents and final guidance documents for 4 documents, originally planned to finish in end 2021 and its objective to explore the factors that need to be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

The guest in this episode represents the sponsor of this show – Nigel Howitt – current chair of PSI.

In the modern workplace, conflict has become a difficult topic. After all, conflict is antithetical to teamwork, employee engagement, and a positive company culture. Or is it?

"No" is a sign of conflict and many avoid saying it by all means. But...

Why is saying no so hard?
How do we say no in the right way?
When should we say no?

Subgroup analyses in combination with data visualisation is one of the hottest topics I can think about. And it hits us as statisticians during our careers again and again.

We need to understand subgroups for efficacy reasons and safety reasons and it's a common question in terms of how consistent your drug works across the different subgroups. It gets even more complicated if you want to review it across multiple studies.

Publishing data is great, but we also want to measure the impact our work has beyond the additional entry in our CVs. During this episode, Mike and I discuss the tools Altmetric and Dimensions. These can help us to understand the reach and influence of clinical and scientific research beyond citations. Based on these, we can track the full journey, from idea to impact. 

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. 

‘I get to sit in the middle of this wonderful web with both Dimensions data and altmetric and I pull the two things together. And together, I can create these translational maps of where research is going from the laboratory through to the hospital and into the broader population.’ - Mike Taylor