On Thursday, 6 February 2025, the Multi-Stakeholder Workshop on Real-World Data (RWD) in regulatory and Health Technology Assessment (HTA) decision-making took place at BfArM, in Bonn, Germany. The gathering brought together key stakeholders from regulatory agencies, industry, academia, HTA bodies, payers, and patient organisations. The event provided a platform to explore collaboration opportunities and share insights from six Horizon Europe-funded projects that make up the MetReal cluster: INSAFEDARE, More-EUROPA, ONCOVALUE, REALM, REDDIE, and Real4Reg.
Key Discussions and Highlights
The workshop started with a warm welcome from Britta Haenisch (Real4Reg) and Karl Broich, President of BfArM, setting the stage for a day of insightful discussions.
After an overview of the MetReal cluster projects, the agenda then focused on two practical use cases from the MetReal cluster, addressing challenges and potential solutions. This session, moderated by Saif ul Islam (INSAFEDARE) and Julia Mader (REDDIE), featured expert insights from the regulatory field (Jörg Zinserling, BfArM), industry (Álmath Spooner, AbbVie), and HTA (Inês Costa, INFARMED, I.P.).
In the following session, guidance and training for regulators, HTA bodies, and other stakeholders were explored. The session was moderated by Cornelia Becker (Real4Reg) and Nora Franzen (ONCOVALUE), and the discussion explored the aims and initial results of the MetReal cluster, featuring contributions from Elita Poplavska (State Agency of Medicines of Latvia), Helga Gardarsdottir (Utrecht University), and Amanda Adler (NICE).
Patient Perspectives and Future Priorities
A key highlight of the workshop was the session on the role of patients in Real-World Evidence (RWE) research, led by Rebecca Moore (Real4Reg). The session featured a presentation by François Houÿez (EURORDIS), titled “Real world data: from own experience with RWD to lessons learnt”.
The event concluded with a panel discussion on future RWD research priorities for regulatory decision-making and HTA. Moderated by Britta Haenisch (Real4Reg), the panel featured insights from Flora Musuamba Tshinanu (FAHMP, Belgium), Dalia Dawoud (NICE), Heather Rubino (Pfizer), Angela Bradshaw (Alzheimer Europe), Rosa Gini (ARS Toscana), and Torsten Hecke (TK).
Britta Haenisch wrapped up the workshop with a summary of key takeaways and next steps, reinforcing the importance of continued collaboration and innovation in leveraging RWD for regulatory and HTA decision-making. The workshop proved to be a valuable forum for fostering dialogue and identifying pathways to enhance the use of RWD in healthcare, ensuring better outcomes for patients and stakeholders alike.