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

New MetReal research cluster launched

On 3rd of March 2023, the REALM partners were invited at the European Commission to meet with representatives of four other projects funded under the same call (HORIZON-HLTH-2022-TOOL-11-02) to kick-off a new cluster called MetReal. The members of the cluster comprise the five research projects REALM, More-EUROPA, ONCOVALUE, Real4Reg and REDDIE.

This cluster focuses on methods to use real-world and synthetic data for regulatory decision making and health technology assessment (HTA) and aims at fostering synergies and increasing the impact of each individual project.

During the event the European Commission and the European Medicine Agency (EMA) gave an overview of relevant tools and initiatives for the MetReal cluster, such as Darwin, working on a federated network and common data model to work with data holders, the EMA qualification advice platform or the EUCAIM and GDI data infrastructures, among others.

The funded projects presented their objectives together with the regulatory and HTA questions pertaining to real-world and synthetic data that are going to be addressed. The members of the cluster exchanged about the data, metadata and standardisation needs as well as about the challenges pertaining to the development of new methods for the use of real-world and synthetic data in the pre- and post-market assessment phases of health innovations. In particular, the types of real-world data that are going to be handled by the various project range from administrative national/EU registries to patient reported outcome data passing by cost, claims reimbursement data, electronic health report, medical device data and so on. Finding smart ways of evaluating the quality of data and synthetic data set as well as the accuracy of the new assessment methods were central points of discussion.

The cluster identified topics of common interest such as collaboration on assessment strategies to evaluate suitability of real-world data, interactions between projects with similar use cases or common white papers and communication products for which synergies could be created. The cluster’s members were also enthusiastic about organising joint real-world data workshops and symposia. All these activities will be organised through a cluster coordinating team with rotations every eight months.