In observational studies or non-interventional studies (NIS) patients take the regular medicine, medical device or undergo a procedure according to the current medical practice. The researcher seeks to exert as little influence as possible to be able to study safety, tolerability and effectiveness of treatments under real life conditions.
Unlike interventional studies that have a set objective and study protocol in a controlled environment, non-interventional studies look at the impact of real-life situations.
Non-interventional research involves a patient who’s medical care falls within current practice and the prescription of the treatment is clearly separated from the decision to include the patient in the study, no additional diagnostic or monitoring procedures are applied to the patients (Article 2(c) of 2001/20/EC) and interviews, questionnaires, blood samples and patient follow-up may be performed as part of normal clinical practice (Section VIII.A of GVP Module VIII)
The purpose of non-interventional studies (NIS) or observational studies is to understand how a drug, medical device or medical procedure performs in real-life situations. These studies provide researchers with important real-life information or real world data that complement the information from controlled clinical trials with information about safety, tolerability and effectiveness of treatments under real life conditions.
Non-Interventional Studies (NIS) are an indispensable tool in the field of medical research. They deliver real world evidence (RWE) about diseases, medicines, medical devices and procedures to continuously increase safety and effectiveness of treatments and therefore contribute to the sustainability of healthcare ecosystems.