Abstract 

While the concept of pragmatic trials is not new, EU and global initiatives to support the generation of high-quality real world data (RWD) from sources such as electronic health records, registries and administrative databases highlight the opportunity to generate fit-for-purpose real world evidence (RWE) through randomised pragmatic trials.

This article summarises the key features of the EFPIA paper, ‘An EFPIA position on randomized pragmatic trials to generate high quality RWE for regulatory decisions’ and a discussion on how such trials can contribute to more patient-centric drug development. It aims to raise awareness and promote a dialogue on this type of study as a valuable tool for evidence generation during the lifecycle of a medicinal product that can inform regulatory decisions about medicinal products.