Finnish Medicines Agency, University Hospitals, and Finnish Innovation Fund Sitra collaborate on Real-World Evidence (RWE) generation for new pharmacotherapies

The Finnish Medicines Agency (Fimea), three Finnish university hospitals, and the Finnish Innovation Fund Sitra have announced a groundbreaking collaboration to test and improve cooperation in producing Real-World Evidence (RWE) on new pharmacotherapies. The partnership aims to assess federated analysis and the Observational Medical Outcomes Partnership (OMOP) data model, with the goal of enhancing understanding of real-world usage patterns and outcomes. By streamlining RWE production, the collaboration aims to facilitate decision making and the rational use of medicines.

Federated Analyses and OMOP Data Model

Federated analysis is a method of data analysis that enables researchers to access and analyze data from multiple sources without physically combining or transferring the data. This approach preserves the privacy and security of sensitive data while allowing collaboration and information sharing among participating institutions.

The OMOP (Observational Medical Outcomes Partnership) data model is a standardized data structure designed to facilitate the integration of observational healthcare data from various sources, enabling more efficient and accurate analysis of patient outcomes.

Goals of the Collaboration

In this collaboration, Fimea will define the research questions relevant for health technology assessment (HTA)/payer decision-making, while the university hospitals will serve as data partners, offering aggregated statistical data for analysis. Sitra is providing financial support for the project as part of their broader mission to foster fair and efficient use of data and to ensure interoperability with international development.

The collaboration will explore the use of federated analysis in the Finnish secondary use of health data infrastructure and adhere to relevant legislation. The Finnish legislative framework shares many similarities with the European Health Data Space (EHDS) proposal, and federated analysis has been implemented in the European Medicines Agency's (EMA) DARWIN EU network.

The pilot will focus on three cases: multiple myeloma, spinal muscular atrophy (SMA), and chimeric antigen receptor T-cell (CAR-T) treatments. The results of this pilot will inform future projects aiming to improve post-launch evidence generation, ultimately contributing to the rational use of medicines.

By piloting RWE generation using federated analysis and the OMOP data model, the partnership aims to build a strong foundation for future international collaborations.

"We are confident that this collaboration will serve as a significant enabler in future international projects, enhancing the exchange of knowledge and expertise in RWE generation," explains Vesa Kiviniemi, the head of HTA at Fimea.

"By working together, we aim to optimize our way of working so it meets the needs of the future, ultimately improving patient outcomes and fostering innovation in the medical field," notes Tarja Laitinen, Director of Research at Tampere University Hospital.

About Fimea:

The Finnish Medicines Agency Fimea is the national competent authority for regulating pharmaceuticals. As a central administrative agency operating under the Ministry of Social Affairs and Health, it promotes the health and safety of the population by regulating medicines, medical devices, blood and tissue products, and biobanks, and by developing the pharmaceuticals sector. In addition to its roles as a licensing and supervisory authority, the Finnish Medicines Agency (Fimea) also produces and compiles assessments of the therapeutic and economic value of medicines and coordinates the related collaboration. The operations focus on the assessment of new hospital-only medicinal products.

About university hospitals and FinOMOP:

In this collaboration pilot, three Finnish university hospitals (HUS, TYKS, TAYS) represent wellbeing service counties and act as data partners in cooperation. University hospitals are part of the open Finnish OMOP network, which  applies the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM), and is also supported by funding from the European Health Data & Evidence Network (EHDEN). The network emphasizes the permanent linkage of Finnish coding to standard vocabularies. FinOMOP is a collaboration that includes three out of five university hospitals, FinnGen, and the Finnish Institute for Health and Welfare (THL).

About Sitra:

Sitra is Finland’s fund for the future. The Health Data 2030 project funds this collaboration. This project aims to create solutions, draw up fair rules and build a bridge for the cross-border use of health data in Europe, and support the competitiveness of the Finnish health sector.

Lisätietoja:

Piia Rannanheimo, johtava asiantuntija, Fimea
p. +358 29 522 3517, [email protected]

Tarja Laitinen, tutkimusjohtaja, TAYS, Pirkanmaan hyvinvointialue
p. +358 50 534 6238, [email protected]

Johannes Ahlqvist, asiantuntija, Sitra
p. +358 294 618 381, [email protected]