Real4Reg – Unlocking Real-World Data with AI
Real4Reg is a consortium of ten European institutions which aims to promote the use of real-world data (national healthcare registers and claims data) to support the regulatory decisions about medicines. Real4Reg will take advantage of ground-breaking technologies such as artificial intelligence and machine learning.
The structure and approach of our project aim to facilitate the implementation of the effective use of real-world data in regulatory decision-making and health technology assessment.
Data & Methods
Real4Reg will use data sources from four European countries (Denmark, Finland, Germany, and Portugal) and will develop solutions to address the data analytical needs of regulatory agencies.
From a methodological point of view, the project is aligned with the decision-making process in regulatory agencies, which can be broadly broken down into the pre-authorisation, evaluation, and post-authorisation phases of the product lifecycle.
Use Cases
Description of Study population: breast cancer, ALS
Real4Reg will assess the value of real-world data from national healthcare registers and claims data in generating high-quality, accessible, population-based information on breast cancer and amyotrophic lateral sclerosis (considering the diagnosis, treatment, and outcomes).
Historical controls and synthetic data: breast cancer, ALS
Real4Reg will demonstrate how the real-world data can contribute to questions that are not typically answered by clinical trials, due to ethical or practical issues. These questions need to be answered for regulatory evaluation and health technology assessment, in the improvement of external validity and statistical power and precision.
Safety: Fluoroquinolones
The overall objective of this use case is to prepare a good practice example for safety analyses of real-world data for the post-authorisation stage and to improve methods for risk estimation in observational data. Real4Reg will also evaluate the impact of regulatory warnings on the use of broad-spectrum antibiotics.
Effectiveness and drug repurposing: SGLT2 Inhibitors
Real4Reg will prepare a good practice example for drug effectiveness and drug repurposing analyses of real-world data for the drug post-authorisation stage. The case of Sodium-glucose Cotransporter-2 (SGLT2) inhibitors will be analysed. These antidiabetic medicines have shown beneficial effects on cardiovascular outcomes in recent years.
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Latest News
Real4Reg Experts Workshop 2026 – 27th January: “Real4Reg Use Case 1: Lessons Learned on Exploring Real-World Data”
Read more: Real4Reg Experts Workshop 2026 – 27th January: “Real4Reg Use Case 1: Lessons Learned on Exploring Real-World Data”Real4Reg aims to incorporate evidence generated from real-world data (RWD) in optimising and supporting the work of regulatory authorities and health technology assessment (HTA) bodies. One of the most important tasks of the project is sharing the results and their implications for society. Therefore, we have the pleasure to announce our upcoming Experts Workshop, scheduled…
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Latest News
Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2025
Read more: Real4Reg Partners’ Participation in Key Events: a Brief Recap of 2025As 2025 has come to an end, now is the perfect time to summarise Real4Reg’s journey throughout the year. The third project year was marked by important conference and workshop participations, spreading Real4Reg’s mission, proposed goals and obtained results.
Upcoming Events
- 27 January 2026 – Online – Experts Workshop – Real4Reg Use Case 1: Lessons Learned on Exploring Real-World Data (Registrations Link: https://forms.gle/9xyurC2pKZ4FBfk69)
- 27-28 January 2026 – Helsinki, Finland – 6th Nordic RWE and AI Conference
- 11-13 February 2026 – Hoofddorp, Netherlands – TRICALS Masterclass 2026
- 24-26 March 2026 – Rotterdam, Netherlands – DIA Europe 2026
Who we are
Our consortium assembles ten partners from six different European countries with experience in the field of RWD analyses, including experts from regulatory agencies and health technology assessment bodies, academia, and patient organisations.
A project for the Patients
Real4Reg integrates two patient organisations to incorporate the patients’ perspectives and expectations along its work.