Study on the use of real-world data (RWD) for research, clinical care, regulatory decision-making, health technology assessment, and policy-making

The main objective of this study was to provide a comprehensive overview of real-world data (RWD) initiatives and their outputs aimed at addressing stakeholders’ needs. Capitalising on machine learning techniques and an extensive interview programme, the study mapped 192 RWDspecific initiatives and their outputs. The study findings were validated through six virtual workshops and other EU-wide consultations with stakeholders. Overall, the study results suggest that the use of RWD is at an early stage. While there are examples of best practices addressing operational, technical and methodological stakeholders’ needs to some extent, these initiatives are mostly proof of concept studies and pilot approaches. Furthermore, these efforts are fragmented into confined disease areas and specific settings with few examples of synergies and exploitation of earlier outputs. The study proposes seven priority action areas that could provide the necessary leverage for widening the use of RWD. These include work on GDPR application to RWD, improvements to accessibility, quality and methods relevant for the use of RWD and a more strategic approach to the use of RWD in health care.