Real-World Evidence for Decisions in Diabetes

DIA Innovating Clinical Trials in Europe Conference

On November 15th, Martina Radanović, REDDIE’s Project Manager from EURICE, showcased the project at the "DIA Innovating Clinical Trials in Europe Virtual Conference." The presentation occurred within the "Real-World Evidence in Regulatory and HTA Decision Making: Report on MetReal Cluster covering 5 European Horizon Europe Projects" session.


From November 15 to November 16, the virtual conference delved into initiatives like Accelerating Clinical Trials EU, European Health Data Space, and Digital Health Technologies. It explored the transformative potential of artificial intelligence (AI) in medicine development, emphasizing ethical considerations regarding fairness, privacy, and transparency. The event also provided insights into regulatory perspectives and requirements.

Representatives from the five MetReal cluster projects, namely More-EUROPA, ONCOVALUE, Real4Reg, REALM, and REDDIE, discussed how Real-World Evidence is reshaping regulatory decision-making and investigated the application of artificial intelligence (AI) in medicine.

All five projects fall under the same Horizon Europe call, aiming to advance the field by exploring innovative approaches to utilize real-world and synthetic data for regulatory decision-making and health technology assessment (HTA). The cluster seeks to enhance the evidential value and usability of these data, contributing to the improvement of regulatory practice and health technology assessment.

In summary, the MetReal cluster projects highlighted the ongoing endeavours to harness the potential of Real-World Evidence and AI in shaping the future of regulatory decision-making. All participants agreed that there are similarities with data challenges they have in their projects and that having diverse stakeholders within the project helps in overall project success. The conference provided a valuable platform for stakeholders to exchange knowledge, promote collaboration, and collectively contribute to advancing innovative clinical trials and healthcare practices.