Non-interventional study

A non-interventional study, or NIS for short, is an epidemiological study or observational study(post-marketing surveillance - AWB) in which no study-related intervention (intervention) such as blood sampling, x-rays on the patient is performed. The data obtained are thus derived from routine treatments of patients and not from additional diagnostics.

According to AMG § 4, a non-interventional study is a study in which findings are analysed on the basis of observations. Therefore, the treatment of patients is not based on a test plan with treatment guidelines, but on medical routine with already approved drugs or medical devices. The protocol that determines the course of the study is called an observation plan, rather than an investigation plan as in interventional studies.

Non-interventional studies have a high external validity and provide conclusions about actual treatment courses. Typical study designs of NIS are cohort studies, case-control studies, cross-sectional studies or descriptive studies without a comparative collective.

Non-interventional studies fall under § 15 of the Professional Code of Conduct (BO) for physicians working in Germany. § Section 15 of the BO applies to all studies outside the AMG and MPG. According to § 15, physicians must report an observational study to the responsible ethics committee before it is started and provide written ethical advice.

Non-interventional clinical trials with medical devices are conducted in accordance with § 23b MPG. Observational studies are not regulated by the AMG. The principles of GCP and the Declaration of Helsinkiapply, so that the protection of the study participant is of central importance. In 2004, a guideline for the assurance of "Good Epidemiological Practice" (GEP) was also issued, which ensures a scientific standard. Through GEP, ethical and moral standards are established, quality in epidemiological studies (NIS) is raised and the validity of research results is strived for. The aim is also to avert fraud and establish public confidence. GEP comprises 11 guidelines and recommendations on the following topics: ethics, research question, observation plan, sample database, quality assurance, evaluation, data protection, contractual framework, interpretation and public health.

While in clinical studies a written consent of the volunteers/patients has to be obtained to conduct the study, in non-interventional studies the patient is informed about data protection. Prior to the start of the study, the patient must give written consent under data protection law for anonymised or pseudonymised data collection and for statistical processing of the personal data collected.