The Effective Statistician - in association with PSI

In this podcast episode, we discuss an important part of leadership – proactive behaviour. Or simply put—drive! As a statistician, your day-to-day approach to this topic will build up to long-term success. We discuss various aspects of the drive including:

What are RWEs or Real World Evidence about? How are Real World Evidence used in determining the value of clinical trials on how they are applied in real-life settings? How are RWEs validated and how are they used in actual medical cases as healthcare procedures are applied in hospitals? What variables tend to affect the way RWE data is managed and used as a reference to actual medical developments...

In this episode, we share out ideas and experiences, which mindset sets up statisticians for success. We cover topics around:

How does patient adherence affect the results of clinical trials? Are there ways to improve patient adherence to medication and treatments not only in clinical trials but also in real-life situations? What is the future of the value of clinical trials in terms of inclusive technological innovations? Clinical trials are designed to test whether a medication would be best for the target population....

Why would a person working under the rules and purpose of statistics for 30 years want something more than what she has been an expert with for many years? Do you want something more out of your statistician background? What could statisticians offer outside of the field of statistics in healthcare? How does leadership in statistics bring you to embrace more exciting journey outside of statistics?...

Why should statisticians aim for becoming good leaders? How do you invest in yourself to become a good leader? How does perseverance change the path taken by a leader in the field of statistics? Gary Sullivan and I team up together to discuss the importance of leadership among statisticians. Understanding the basic factors of leadership and how it makes an effective statistician is important for e...

Publications are part of the bigger communication plan which also covers PR, scientific dialog, promotion, training, and internal communications. Writing publications should follow an overall strategy for the compound or therapeutic area. They are necessary for further steps like having promotional material, HTA submissions, scientific/medical dialog, etc. They should not be an afterthought or see...

What is a secondary paper? What is its typical content? Where is the content coming from? A secondary paper is a paper you do once you are done with your primary paper. I've been working on this for a long time and always have fun doing it. Together with Benjamin, we discuss the following points:

Feeling comfortable does not lead to growth. But why do most people stay in their comfort zone? Are your own expectations holding you back? In this episode, I am talking about the reasons why people stay in their comfort zones and always choose the “safe side”. And why choosing this hinders you from your personal and career growth.

I am really passionate about leadership and Claude Petit is also passionate about building leaders and being an effective leader. Together, we will share with you how to become a statistical leader and how to build such an organization. So stay tuned!

What is a pharmacometrician? What does the training of a pharmacometrician look like? In my career, my experience of working with pharmacometricians was very limited because I spent most of my time working more on the later phases; and the contact with people in that space of the industry is not that big, that's why I found this episode really helpful. If you don't have a clue what they do then st...

What can go wrong with network meta-analyses? You often have multiple endpoints but these are not collected consistently across all the studies included in the NMA. How do you deal with this? Even with the same variables assessed over studies, they might be collected at different time points. This often has an effect on both efficacy and safety results. What do you do? Your placebo treatment might...

In today's episode, I am the interviewee, and Jenny is the one asking the questions. We are talking about how training in launch and commercialization can be a super weapon, what its role is, and how can this be developed and administered for non-statisticians. We also talk about the following interesting points:

The world has changed, and it will not turn back to what is used to be before the pandemic. This comes on top of other trends, like the increased use of data across all aspects of data. The hunger for talent in the data science space has dramatically increased, and it is not only coming from the Apples, Googles, and Amazons. Other trends are the increase in prices, the shifts in motivations of emp...

I first became aware of these sources for real-world evidence some years ago, and I tried to get an expert on this topic so often, but unfortunately no one would speak with me. Then finally someone agreed when they found out what country my research was being conducted in-the Scandinavian Union! You might be wondering why we need data from such a unique place as Scandinavia? Stay tuned because you...

Is a board of directors essential for everyone? Is it necessary for it to come from within your company? This episode is all about career advise. Together with Heather, we talk about having your personal board of directors and how could this concept help you have a career advancement overtime.

We all need to present frequently and the more you progress with your career the more important the presentations become. Messing these presentations up - especially in front of those responsible for your next promotion - will lead to bad career outcomes.

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 appro...

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 publishin...

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 d...

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 exis...