Future implications of EU HTA and how Next Gen get involved
The Effective Statistician - in association with PSI
00:00
Is the HTA Regulation a Hot Topic?
In the HTA process some endpoints are more weight than what they have currently in the regulatory field. So thinking about PROs for instance and the safety. I see that all the time at the moment in oncology but also in rare diseases That's an important topic you have maybe small studies or single arm studies and or randomized studies. But the comparator is very small from the sample size perspective and what do you do with that? What are the kind of hot topics in this area at the moment? The FDA is coming around a little bit, there's more embracing this area.
Transcript
Play full episode
