unlocking real-world data with AI

Funding Information: Real4Reg started in January 2023 and has a 48-month duration. The project is funded by the European Commission within the Horizon Europe Framework Programme (grant agreement 101095353) and is part of the MetReal cluster in which six projects collaborate to promote synergies. In the MetReal cluster, Real4Reg is unique as it spans the entire spectrum from highly relevant use cases for RWE from regulatory and HTA practice across the product lifecycle. The Real4Reg consortium consists of 10 partners from 6 European countries with experience in the field of RWD analyses. Experts from regulatory agencies and HTA bodies, academia and patient organizations are part of the consortium. The project has three overall objectives. It aims to enable the use of RWD and RWE by developing user-friendly data-driven tools and technologies for the effective analyses of RWD in regulatory decision-making and HTA. To establish the value of RWD and RWE on regulatory decision-making and HTA, Real4Reg will integrate the methods developed as part of the first objective into tool packages to provide scientists within health regulatory and HTA bodies with ready-to-use methodological standards. The results will inform training activities on good practice examples and will be informative for existing and emerging guidelines for both health regulatory authorities and HTA bodies across Europe. Funding Information: Open Access funding enabled and organized by Projekt DEAL. The research leading to these results has received funding from the European Community\u2019s Horizon Europe Programme under grant agreement no. 101095353 (Real4Reg). Views and opinions expressed are those of the authors only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union or the granting authority can be held responsible for them. Publisher Copyright: © The Author(s) 2025.