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 …
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 »
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 »