NIS - Non-Interventional Studies
A NIS is not designed to realize study specific intervention. They are launched when the intervention (therapy) is already approved and on the market. A NIS collects additional information on the product by observing the patietens and customers under "every day life" conditions.
Realised prospectively, it basically means: sampling the data systematically. A NIS is primarily intended for post market surveillance of approved drugs and products. The NIS aims to document practical aspects under "normal use" conditions .
An NIS can provide new, previously unknown side effects. It can be used for the documentation of the patients compliance and the substance adherence, and the observation of practicality in routine use.
It creates a descriptive data set. Without controll group like in an analyrical study no causal conclusions can be directly drawn fron the data.
NIS are ideal for the generation of hypotheses, they are not in competition with clinical trials.