What is a Non-Interventional Study?

A non-interventional study (NIS) is a broad term that includes any type of research in which patients are treated as they otherwise would in the real world. This can include retrospective studies utilizing sources such as patient charts, electronic health record data, administrative claims data, or patient registries as well as prospective registries that do not have an interventional component. Typically, the term NIS (or NIR for non-interventional research) is used to describe studies of medical or clinical nature and not market research. Much of the research that health economics and outcomes research teams conduct falls under the umbrella of NIRs. Depending on the type of study, there may be requirements to collect certain types of information (especially in prospective registries) such as adverse event data depending on the country in which data are being collected.