Have you been considering a one-armed observational study or asked to work on such a study? As a statistician, it is important to understand the scientific but even more the political background of such studies. In this episode, we will discuss one-armed observational studies and why they are, in most cases, not a good idea. …
Today I’m talking with Rachel Tham, a principal statistician, about a book that has been incredibly impactful in both of our lives—Deep Work. We discuss what deep work is and how it can help statisticians at work. Deep work is a concept developed by Cal Newport which encourages people to focus intensely on one task …
Are you a statistician working in the pharmaceutical industry and never got in touch with economic modelling and network meta-analyses? Then you should listen to this episode! The EU HTA will not only affect all statisticians in the pharmaceutical industry with respect to skill sets and collaboration (we talked about that in podcast #3), but …
What will be the role of health economics in the future EU HTA? Read More »
All statisticians in the Pharmaceutical Industry will be impacted by the new EU HTA regulation. Activities around HTA submissions will happen earlier than currently, in parallel to the regulatory approval process for marketing authorization. There will be an increased scope of evidence for the joint clinical assessment to fulfill the needs of all EU member …
Future implications of EU HTA and how Next Gen get involved Read More »
End of last year, a congressional report about the approval of an Alzheimer drug by the FDA was published. It critiques both the FDA and the sponsor company Biogen. Reuters and many other major news organisations reported about it. Today, I interviewed Anja Schiel about this topic. We talked about the background of Alzheimer and …
If you’re a statistician working in a regulatory setting, you’re probably familiar with estimands as a way to frame the clinical question of interest. But what’s the role of estimands beyond regulatory approval, in a Health Technology Assessment setting? That question is especially important these days where the framework for pan-European HTA is taking shape. …