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

DIA Innovating Clinical Trials in Europe Conference

On Wednesday, November 15th, our project co-coordinator, Dr Gokhan Ertaylan from VITO, presented the aims of the REALM project at the DIA Innovating Clinical Trials in Europe Virtual Conference. The presentation took place during the "Real-World Evidence in Regulatory and HTA Decision Making: Report on MetReal Cluster covering 5 European Horizon Europe Projects" session.


Representatives from the five MetReal cluster projects discussed how Real-World Evidence is reshaping regulatory decision-making and explored the potential of artificial intelligence (AI) in medicine.

The five research projects, namely More- EUROPA, ONCOVALUE, Real4Reg, REDDIE and REALM, fall under the same Horizon Europe call that 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 DIA Innovating Clinical Trials in Europe virtual conference addressed initiatives such as Accelerating Clinical Trials EU, European Health Data Space, and Digital Health Technologies. It delved deeper into the groundbreaking potential of artificial intelligence (AI) in medicine development, reflected on ethical considerations, ensuring fairness, privacy, and transparency, and provided insights into regulatory perspectives and requirements.

Participants had the opportunity to learn how Real-World Evidence is transforming regulatory decision-making and placing patients at the centre of discussions.

Overall, the MetReal cluster projects highlighted the ongoing efforts to harness the potential of Real-World Evidence and AI in shaping the future of regulatory decision-making. The conference served as a valuable opportunity for stakeholders to exchange knowledge, foster collaboration, and collectively contribute to the advancement of innovative clinical trials and healthcare practices.