Multi-Stakeholder Workshop on RWD in regulatory and HTA decision-making held in Bonn
On February 6th, members of the REDDIE consortium 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, Germany. This pivotal event brought together a diverse array of stakeholders, including representatives from regulatory and HTA agencies, academia, the European Commission, industry, patient organisations, payers, and key initiatives focused on advancing the use of RWD in Europe.
The workshop was organised by Real4Reg in collaboration with other MetReal cluster projects – Insafedare, More-EUROPA, ONCOVALUE, REALM, and REDDIE. Together, these initiatives are committed to leveraging RWD to support real-world evidence (RWE), enhance regulatory decision-making, and promote competence-building among researchers and regulatory bodies.
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, incorporating patient perspectives into real-world evidence research was emphasised, ensuring findings remain relevant and impactful. The event also included a forward-thinking panel discussion on research priorities for RWD, exploring both future opportunities and potential challenges in its broader adoption across the EU.
REDDIE coordinator Julia Mader moderated a discussion on RWD use cases from the MetReal cluster, while WP3 Leader Amanda Adler participated as a panellist, offering insights on guidance and training for regulators, HTA bodies, and other stakeholders. Amanda emphasised the significance of evaluating methodologies that contribute to the development of guidelines, particularly in the context of disease-specific characteristics. Stakeholder discussions highlighted that while RWD may not provide solutions to every challenge, it remains a crucial tool for improving patient care and healthcare decision-making, as having real-world insights is preferable to relying solely on limited data or assumptions.
The REDDIE consortium sincerely appreciates the meaningful discussions and valuable contributions from all attendees. The engagement and expertise demonstrated throughout the event underscore a shared dedication to strengthening regulatory support and cultivating a comprehensive evidence framework to advance healthcare decision-making.
By continuing to work together, we can unlock the full potential of RWD in generating high-quality RWE, guiding regulatory frameworks, and strengthening the competence of researchers and stakeholders. Let’s drive innovation and shape the future of data-driven healthcare in Europe!
