ABSTRACT
Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the undeniable importance of the topic, in Italy numerous difficulties persist, mainly linked to two aspects: the impact of privacy regulations, especially in the case of retrospective research; a gap between methodological and regulatory definition. Here we aim to provide an overview of the state of the art of observational research in Italy to draw attention to this issue and spark debate within the international scientific community. In the absence of a competent authority that can enact laws in this context, it is important that the scientific community is made aware of the issues and puts up a united front to foster a cultural change.

IMPACT STATEMENT
The purpose of this paper is to stimulate a discussion within the scientific community aimed at accelerating the publication of new guidelines on observational drug studies and, hopefully, the publication of standards covering all types of observational research.