Advancing Real-World Data Healthcare Research and Decision-Making Across Europe
Real-world data (RWD) is playing an increasingly vital role in shaping healthcare research and decision-making across Europe. By capturing insights from real-life clinical practice, RWD enhances real-world evidence (RWE), enabling regulatory bodies, policymakers, and researchers to make informed decisions that improve patient outcomes. As the European healthcare landscape evolves, the integration of RWD is crucial for refining treatment guidelines, accelerating innovation, and ensuring that healthcare solutions are tailored to real patient needs. Collaborative efforts like REALM, REDDIE, and other MetReal cluster initiatives are at the forefront of harnessing RWD to support evidence-based policymaking and regulatory advancements.
On February 6th, members of the REALM and REDDIE consortium, both projects supported by RISE and sister company EURICE, actively participated in the first Multi-Stakeholder Workshop on Real-World Data (RWD) in regulatory and Health Technology Assessment (HTA) decision-making, held at BfArM in Bonn.
This significant event united a broad spectrum of stakeholders, including representatives from regulatory and HTA agencies, academia, the European Commission, industry, patient organizations, payers, and key initiatives dedicated to advancing the use of RWD in Europe. Organized by Real4Reg in collaboration with the MetReal cluster projects—Insafedare, More-EUROPA, ONCOVALUE, REALM, and REDDIE—the workshop underscored a collective commitment to utilizing RWD to strengthen real-world evidence (RWE), enhance regulatory decision-making processes, and foster competence-building among researchers and regulatory professionals.
The workshop featured insightful presentations on early project results, along with a thorough examination of two real-world data use cases. Participants engaged in dynamic discussions on training and guidance strategies designed to equip regulators, HTA bodies, and stakeholders with the expertise needed to effectively implement RWD. Additionally, the importance of incorporating patient perspectives into real-world evidence research was emphasized, ensuring that findings remain relevant and impactful. The event also included a forward-thinking panel discussion on RWD research priorities, exploring future opportunities and potential challenges in its broader adoption across the EU.
Gabrijela Radić, Senior Project Manager for project REALM and Managing Director of RISE emphasized the significance of the organization's role in shaping the EU RWD framework, stating: ‘’We are proud to contribute to transformative projects like REALM and REDDIE. Our efforts reinforce our dedication in supporting relevant research projects across Europe and enabling them in their challenging journey to bring significant change to European health ecosystem.’’
Through ongoing collaboration with diverse stakeholders, we can fully harness the power of RWD to generate robust real-world evidence (RWE), inform regulatory frameworks, and enhance the expertise of researchers and decision-makers. Together, we can foster innovation and shape the future of data-driven healthcare across Europe.
