Non-interventional studies (NIS)
After the market approval, non-interventional studies (NIS) provide important findings on long-term effects, drug safety as well as the application in everyday routine. Additional factors like concomitant medications, concomitant diseases or compliance can be investigated and therefore efficacy and safety of the pharmaceutical can be further improved.
The non-interventional study is an investigation, in which epidemiological methods are used to analyse data of the treatment of persons with pharmaceuticals. The treatment is conducted according to the clinical routine and summary of product characteristics.
- Continuation of clinical investigations for market approval as follow-up
- New clinical investigations
- Surveillance studies (Data collection under routine conditions)
- Evaluation of register data
- Analysis of relevant retrospective data
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