[Real-world evidence]

Abstract

Real-world evidence is among the most frequently discussed issues at professional medical conferences and meetings. It refers to data and information derived from sources such as electronic health records, disease or product registries, and observational research. Looking for an accelerated approval of new pharmaceutical products and devices, real-world evidence is considered a useful tool to confirm data collected for regulatory purposes. Anyway, randomised controlled trials still remain the gold standard of clinical research, in order to minimize bias and to evaluate the effectiveness of a clinical intervention. A pragmatic approach and quasi-randomised trials to shorten length and costs of the studies can be considered. The problem lies with the quality of data rather than with the context in which evidence is gathered.