1. Introduction. Randomised controlled trials (RCTs) are considered the “gold standard” to establish drug efficacy, but they have typically a short follow-up and include only a limited number of patients, which rarely allows to assess safety appropriately. In addition, RCTs generally include highly selected patients and use strict protocols, which may not be representative of the challenges patients and health professionals face in real-life. By contrast, non-randomised studies, such as observational studies or epidemiological studies, have typically large numbers of patients, long follow-ups and highly heterogeneous study populations, which may allow to study subgroup of patients with different characteristics or establish generalisability in a less homogenous population. Therefore, real-world studies are increasingly recognised as an important mean to evaluate drug safety and effectiveness, and pharmaceutical companies are now more than ever required to demonstrate a real-life perspective in the regulatory process [...].