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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
The world of healthcare continues to change, and it’s important to keep up with the latest advances in technology and research. That’s why I’m excited to talk with Shirley Wang, one of the leaders of RCT Duplicate, a study focused on duplicating randomized clinical trials through real world data. She is currently leading
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
Why are companies often running single arm studies in development? What are the potential drawbacks and why is it not a binary choice between full comparative study and single arm trial? What are solutions in between to find a balance between feasibility and rigour? Single arm studies are a popular
Reproducible research is a key part of research in the pharma industry. It allows for transparency, understanding, and accuracy in the research process. But how can you make your research more reproducible? Today, I talk with Heidi Seibold who has dedicated her career to helping researchers become more reproducible. Let’s
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
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
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
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
Are you a statistician, data scientist, or healthcare specialist looking for the perfect conference to attend? The Effective Statistician Conference 2023 is an exciting opportunity for statisticians, health care specialists, and data scientists to come together and learn from industry experts, exchange ideas, share breakthrough advancements in statistics, collaborate with peers,
As a statistician, have you ever wondered—why are statistical analyses for HTA dossiers differ from those in regulatory dossiers? Aren’t they both just benefit-risk assessments? In this podcast, we review some of the history and background of how HTA and regulatory decision making have common sources of information, but different
Are you curious about aggregate safety assessment planning? Whether you’re an experienced statistician or just starting out in the field, your work increasingly demands that you apply principles of aggregate safety assessment planning. With an ever-changing and advancing landscape filled with data and technology advancements, it is essential to stay
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