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Real-world-data enabled assessment
for health regulatory decision-making

MetReal cluster

As the pharmaceutical and medical device industries increasingly rely on real-world data (RWD) and synthetic data, regulators and HTA bodies face the challenge of conducting targeted validations to independently verify claims independently.

Through collaborative efforts, the cluster aims to advance the field by exploring innovative approaches to leverage real-world and synthetic data for regulatory decision-making and HTA. By improving the evidential value of these data and promoting their usability, the cluster aims to contribute to improving regulatory practise and health technology assessment.

The five research projects, namely REALM, More- EUROPA, ONCOVALUE, Real4Reg and REDDIE fall under the same call - HORIZON-HLTH -2022- TOOL -11-02.

More-EUROPA – visit the website

Real-world data (RWD) has the potential to contribute to the understanding of drug effects alongside clinical trials. The project focuses on patient registries as a type of RWD and aims to formulate methodologies and standards to establish these data as evidence for the regulatory approval and health technology assessment of medicinal products in Europe.

REDDIE – visit the website

REDDIE aims to support the use of RWD collected from a variety of sources such as devices, wearables, and electronic health records for the management of diabetes mellitus, a chronic disorder that affects millions of people worldwide. The consortium will use data from national registries to assess the outcome of specific interventions. Moreover, it will establish standards for accepting and implementing RWD in the process of evaluating medicines and other interventions for the prevention and treatment of diabetes.

Real4Reg – visit the website

The evidential value of data for broader use cases, such as in the pre-authorisation and evaluation phase of medicines, is limited by the variability of data and the challenges of analysing data from different environments and sources. The project focuses on developing new and optimised methods for RWD analysis relying on highly relevant use cases from regulatory practise and the entire product life cycle. Real4Reg will implement the results into existing and emerging guidelines for health authorities and health technology assessment bodies across Europe.

ONCOVALUE – visit the website

The key objective of the ONCOVALUE project is to collect and analyse RWD from European cancer hospitals and institutes as a means of assessing the effectiveness of novel cancer therapies. The consortium will use AI technologies to transform unstructured data from medical notes and images into real-world evidence made available to clinicians for treatment decision-making, and to regulatory bodies for developing guidelines. Collectively, ONCOVALUE will contribute to safer and more efficient therapies and technologies.

Other related initiatives

The European Health Data Space (EHDS) is an initiative led by the European Union to establish a protected and distributed digital infrastructure for the transfer and collaboration of health data among member countries. Its primary objective is to enhance health research, patient care, and disease prevention by enabling access to top-notch health data, all the while safeguarding patient privacy and data security.
Visit the EHDS website.

The Data Analysis and Real-World Interrogation Network (DARWIN EU®) is a collaborative effort between the European Medicines Agency (EMA) and the European Medicines Regulatory Network. It aims to establish a coordination centre that gathers accurate and timely evidence on the utilization, safety, and efficacy of medicines for human use, including vaccines. This evidence is derived from real-world healthcare databases across the European Union (EU).
Visit the DARWIN EU® website.

The Towards European Health Data Space (TEHDAS) is an initiative led by the European Union, with the objective of establishing a secure and privacy-focused ecosystem for the exchange and analysis of health data throughout Europe. Its primary aim is to enhance research and innovation, advance healthcare delivery and outcomes, and bolster the resilience of health systems.
Visit the TEHDAS website.