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 digital twins: 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.
Latest News
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Real4Reg Partners Convene for Productive Virtual Meeting
Read more: Real4Reg Partners Convene for Productive Virtual MeetingOn September 11th, the Real4Reg project partners convened virtually for a meeting that addressed key aspects of the collaborative initiative. The meeting covered a range of topics, including progress reports from working groups and challenges in OMOP mapping and data access. Despite the virtual format, participants engaged actively, demonstrating their commitment to advancing their collective…
Latest Events
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Real4Reg Consortium Meeting in Copenhagen
Read more: Real4Reg Consortium Meeting in CopenhagenThe Real4Reg consortium had its first hybrid meeting in the Danish capital city. The gathering brought together all consortium partners and advisory board members for productive discussions and presentations on the progress of the work packages and was hosted by the Danish Medicines Agency (DKMA) in collaboration with the Consortium coordinator, the Federal Institute for…
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.