The three overall objectives of Real4Reg, considering the application of real-world evidence (RWE) from real-world data (RWD) in regulatory decision-making and HTA are:
- to enable the use of RWD/RWE
- to establish the value of RWD/RWE
- to impact RWD/RWE use and analyses.
Real4Reg is providing solutions for the data analytical needs of health regulatory and HTA bodies across the EU in the field of RWD and artificial intelligence/machine learning, i.e., historical controls, and synthetic data. It is delivering usable standards for regulatory decision-making and HTA as well as methods for fit accuracy, management, analysis, and the interpretation of RWD and synthetic data. Real4Reg is defining new and optimised guidance and training concepts that can potentially be applied across the product lifecycle and across all EU countries. This is being achieved through collaboration with other initiatives involved in establishing the European Health Data Space (EHDS) as well as in exchange with neighbouring projects within the same call (MetReal cluster).
Read the project’s position paper here to learn about the objectives and structure of the Real4Reg project.