Observational / Non-interventional Studies
Observational or Non-Interventional Studies (NIS) investigate various aspects of drug use, including efficacy and safety, under real-life conditions. NIS are defined by methodological approach, and not scientific objectives.
From an EU regulation perspective, a study qualifies as non-interventional and does not fall under the scope of the clinical trials directive 2001/20/EC, provided the following requirements are cumulatively fulfilled:
- Medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorization
- Assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study
- No additional diagnostic or monitoring procedures are applied to the patients, and epidemiological methods are used for the analysis of collected data. Of note, interviews, questionnaires, and collection of blood samples may be performed as part of normal clinical practice
For non-interventional studies in Europe, there is little to no homogeneity from one country to another in terms of regulation, documents to be submitted, submission timelines, or processes. In addition, the regulatory bodies involved vary greatly across geographies. Mapi has extensive experience of the preparation of ethical submissions, and can perform the necessary submissions for these studies.