Project Lead: Claudia Wild
Author: Ozren Sehic
Publication: August 2021
Language: German (with Englisch summary)
Non-interventional studies (NIS) are observational studies that evaluate medicinal products and medical devices in routine care after market authorization in their approved indications. For some years now, there has been a critical discussion about their role, whether they are a valuable source of knowledge or a marketing instrument. In Austria, NIS are not subject to approval, but they are subject to notification. The NIS must be registered in a study database (register), in which some (but not all) information is also made publicly accessible. This systematic analysis addresses the questions of how many non-interventional studies are being conducted in Austria, who is responsible for them and what the knowledge interest of the registered NIS is.