The healthcare industry is constantly developing, and with it come new regulations and guidelines that businesses must adhere to. One regulation that has recently been set in Germany is the 15% threshold for relevant improvement for some endpoints used in clinical trials. Many have critiqued this threshold. It’s important for all statisticians (not only for …
The 15% Threshold in Germany and Why You Should Care Read More »
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 method for collecting data despite …
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 »
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. …
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 utility functions for how they …
What is EU HTA and why should statisticians care? Read More »