RWE 201 – EU – EU’s Action Plan for Real-World Data (RWD) & RWE
The European Union has embarked on an ambitious journey to weave Real World Evidence (RWE) into the fabric of its healthcare system. The strategy, underscored by a comprehensive multi-year plan, focuses on harnessing the power of real-world data (RWD) through collaboration, standardization, and innovation. The infrastructure for this integration outlines seven pivotal components: Terminology, Findability, Access, Quality, Advanced Analytics, Use, and Use Cases.
RWE 2020 – The Foundation: The EU emphasizes on the importance of RWD Collection and RWE Generation. Key pillars of this foundational year include:
– Enhancing collaboration nationally and across borders.
– Creating a robust framework with effective methodologies.
– Recognizing the role of RWE in supplementing clinical trials.
– Aiming to support decisions by regulators, HTA, and payers.
– Advocating support for healthcare providers.
2021:
– Focuses on access to RWD and the establishment of the EU4Health Program.
– Introduction of new legislations: Artificial Intelligence Regulation, Health Technology Assessment Regulation, and laws on RWE Value and RWD Access.
– Notably, a step towards centralized data governance with the European Health Data Space Regulation.
2022:
– Expands on the RWE Use Cases with guidelines and draft laws.
– Emphasis on medicinal product regulations.
– The Data Governance Act aims to support data access and streamline data utilization.
2023:
– Proliferation of RWE use cases continues.
– Medicinal Products Regulation is in the limelight alongside explorations into single-arm trials by EMA.
– The year marks a notable focus on AI with the EMA’s guidance on Artificial Intelligence.2024:
– The direction is set towards advanced RWD analytics and a broader scope of RWE Use Cases.
– Introduces a Catalogue of NIS using RWD Sources and a focus on RWD findability with source catalogues = The replacement for the EU PAS Register
This roadmap not only outlines the EU’s commitment to innovative healthcare solutions but also sets a precedent for global health systems to leverage real-world data and evidence for enhanced patient care.
Share this story...
Denmark – A Hub for RWE Research
RWE 201 - Denmark – A Hub for RWE Research Denmark has been at the forefront of real-world data (RWD) and real-world evidence (RWE) initiatives in the realm of [...]
NORWAIT – A Cautionary Tale
RWE 201 - NORWAIT – A Cautionary Tale Norwait Study: https://rwr-regs.com/norway-norwait-study-deterioration-for-several-participants-in-a-controversial-observational-cancer-study/Observational studies, as the term implies, typically involve low to no risk for patients. Their main purpose is to [...]
Norway – Real World Data Initiatives
RWE 201 - Norway – Real World Data Initiatives Norway has made significant strides in real-world data (RWD) and real-world evidence (RWE) initiatives, particularly within the healthcare [...]
Sweden – Pioneering the Use of RWD
RWE 201 - Sweden – Pioneering the Use of RWD Cancer Registry: https://www.socialstyrelsen.se/statistik-och-data/register/cancerregistret/Sweden has been a pioneer in several real-world data (RWD) and real-world evidence (RWE) initiatives, particularly in [...]
Finland – Leaders in Integrating RWE into Healthcare, Policy, and Research
RWE 201 - Finland – Leaders in Integrating RWE into Healthcare, Policy, and Research Finland – Secondary Use of Health Data: https://stm.fi/en/secondary-use-of-health-and-social-dataFinland has been a frontrunner in the utilization [...]
Italy – CCNCE – Ethical and Regulatory Issues in the Processing of Patient Data in Observational Research
RWE 201 - Italy – CCNCE – Ethical and Regulatory Issues in the Processing of Patient Data in Observational Research CCNCE Reflection Paper (Apr 2023): https://www.aifa.gov.it/documents/20142/1808580/Criticita_etiche_ricerca_osservazionale_06.04.2023.pdfThe Italian National Coordination [...]
