Working Group Mission

The Working Group - also through constant and fruitful collaboration with the Institutions and other scientific societies - aims to improve the cultural and regulatory environment so that in Italy the most appropriate conditions are implemented and maintained to design and conduct observational studies with high clinical-scientific, ethical and methodological value.

Researches using observational methods based on Real World Data are the most frequently used study model in the epidemiological field, where the objectives are the description of a pathology or of its complication and / or of a diagnostic-therapeutic process. In case the objective is to evaluate a possible cause-effect relationship between two or more variables, in the presence of an agent, in the observational study there is no control over the exposure to the same agent in order to evaluate the outcome. Therefore, we speak of passive exposure to a determinant that can be natural (eg: age, sex, solar radiation), socio-cultural (nutrition, lifestyle, socio-economic conditions), a drug, a therapy, or an assigned surgical intervention. However, within the normal medical practice routine, regardless the execution of the study itself, in these types of study the researcher acts as an "observer" and does not exercise any role in the assignment of the determinant, thus differentiating himself from the researcher who, in the context of a clinical trial, decides and controls the exposure through random assignment of treatments (randomization), experimental design and operational procedures.

Working Group activities:

  • Organization of seminars and conferences on topics related to observational research and Real World Data
  • Teaching for University Masters promoted or sponsored by SIMeF
  • Collaboration with the main public institutions involved (Ministry of Health, AIFA, Data Protection Authority, etc.) and other organizations in order to keep the legislation constantly updated

Members interested in actively participating in the development of the initiatives of this working group are invited to write to: This email address is being protected from spambots. You need JavaScript enabled to view it.