non-interventional study (NIS)
In contrast to clinical studies, a non-interventional study deals with drugs and pharmaceutical products that have already received regulatory approval. Based on a predefined observation plan in which case numbers, evaluation methods and explicit observation questions are documented, the selected patients are treated under normal practice conditions. The reason for not having specific guidelines for treatment and/or diagnosis is to observe and record drug use under realistic conditions and to analyze the results. Parameters such as concomitant medication and compliance can also be specifically considered. In contrast to participants in a clinical study, participants in a non-interventional study do not require any additional insurance. Since the drug has already been approved on the market, the drug manufacturer is liable for any application complications that arise.
Non-interventional studies can be divided into several types:
- Application observations
- Cohorts studies
- Case-control studies
- Register studies
The aim of such a study is to establish a precise side-effect profile. Furthermore, it is used to record the effects on quality of life. Another special feature of NIS is that competent authorities do not have to grant permission to conduct it, but only have to be informed about it. Only the ethics committee must advise on the study before it begins. The number of study participants is significantly higher, averaging several tens of thousands of subjects treated in various research centers.