The Risk of Not Collecting Background Data in Clinical Trials

The problem is you can't really win. You don't have the same endpoints that you collect in your observational study compared to your external data. And also, when you have these observational studies at the start of the launch period, you have very different patients included. So it means that also the responsibility for us to work on this and especially on the safety side of things, to have a close look of what's going on there is immense.