The STRATA-FIT General Assembly Meeting took place on 11-12 June 2024 at the Medical University of Vienna, Austria. The meeting brought together the consortium partners, both in person and online, including the members of the Patient Advisory Panel.
During the meeting, the progress of STRATA-FIT was reviewed and collaboration among partners was refined. The productive discussions provided guidance on the next steps, ensuring the project continues to move forward in an efficient manner.
As we mark the end of the first year of our six-year project, we are pleased to share the progress and key achievements across the work packages, highlighted during our annual project meeting.
WP1 – Project management (Lead: UMC Utrecht)
In the first year of the project, we have successfully submitted eleven deliverables across various work packages. As part of its ongoing responsibilities, WP1 ensures the coordination of deliverables, including those involving multiple partners, to streamline communication and collaboration. Additionally, WP1 is preparing for the next reporting cycle, which includes technical and financial reports due every 18 months, with the first one ending in October 2024. Emphasis has been placed on adhering to the budget and ensuring all costs are eligible and verifiable under Horizon Europe guidelines.
WP2 – Development of real-world RA cohort and technical integration of data (Lead: Karolinska Institutet)
WP2 has made significant strides in harmonizing diverse datasets from consortium partners, essential for efficient data analysis. Efforts have included updating data management plans and version control strategies, preparing for data integration challenges, and evolving data definitions. This work is crucial for the identification and collection of longitudinal data from clinical partners, ensuring that differences in data structures and variables do not impede concerted analyses. The infrastructure development for data analysis is a key focus to enable robust, federated analyses required by the project.
WP3 – Data analytics and model development (Lead: UMC Utrecht)
WP3 has initiated the development of decision aid tools and treatment recommendations, beginning with comprehensive literature reviews to explore strategies for identifying D2T phenotypes. The work has also involved adjusting timelines for deliverables to align with project phases and review outcomes. Collaborative analyses with all partners contributing data are underway, utilizing the project’s Federated Learning infrastructure. A Consensus Board is being established to guide the modelling process, ensuring the choice of model types, variables, and predictive performance is suitable for decision-making.
WP4 – Development of decision support tools (Lead: Medical University of Vienna)
WP4 is focused on the development of a software called “Decision Aid,” designed to identify patients with D2T RA and provide treatment guidance. This year, a systematic literature review was discussed and scheduled for completion by March 2025. Key activities included exploring partnerships for tool development and creating a personalized management algorithm. The first version of the Decision Aid, intended as a proof-of-concept, will validate its functionality and reliability before developing a final version with full functionality for use in a clinical study intervention phase.
WP5 – Prospective intervention pilot study (Lead: Semmelweis University & UMC Utrecht)
WP5 has prepared clinical trial documentation and patient stratification strategies for the upcoming pilot study, ACCESS-STRATA. The study will evaluate the feasibility, effectiveness, and cost-effectiveness of a tailored treatment approach for D2T RA patients. Utilizing the Federated Learning infrastructure and the STRATA-FIT decision aid, WP5 plans to identify and confirm D2T RA patients and phenotypes, and propose patient-tailored treatments. The study will recruit 175 patients for the observation phase and an additional ~88 for the intervention phase, depending on the drop-out rate from the observation phase.
WP6 – Biobanking and biomarker analysis (Lead: Klinikum der Universität München)
WP6 has identified and validated potential biomarkers through existing data and established a robust biobanking protocol. Key activities included developing standard operating procedures for blood and tissue sampling, creating a biomarker analysis plan, and establishing a central biobank database. Collaboration among all centres is ongoing to identify variables for assessment and ensure compliance with biobanking protocols. Historical data from a previous study involving hundreds of patients is being leveraged, pending necessary permissions.
WP7 – Good governance (Lead: Medical Data Works)
WP7 has addressed the legal and regulatory aspects of AI applications as medical devices, planning pilot studies to validate AI models in clinical decision-making. The distinction between studies using medical devices and those not is crucial for compliance with new laws regarding data sharing and AI use. WP7 aims to ensure that computational models meet the necessary safety and performance standards, adhering to Medical Device Regulation and GDPR guidelines. Pilot studies will assess the efficacy of these models across diverse patient populations.
WP8 – Communication, dissemination and exploitation (Lead: Instituto de Medicina Molecular João Lobo Antunes)
WP8 has discussed communication strategies, including newsletters and social media platforms, to enhance project visibility. Website updates and content enhancements have been planned to improve dissemination. This work package is responsible for ensuring efficient and effective dissemination of the project’s approaches, goals, and results to stakeholders. Additionally, WP8 coordinates the STRATA-FIT Patient Advisory Panel, ensuring research activities align with patient needs and facilitating the translation of results to clinical practice.
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The active participation of PAP members – Bertha Maat, Birgit Barten, Irene Pitsillidou, Slađana Rumpl Tunjić, and Sofia Valpereiro – added valuable patient-centred perspectives to the discussions in Vienna.
Prior to the General Assembly, a PAP meeting was held, gathering insights from the patient experts. Their feedback on the patient involvement strategy and suggestions for improvement were later shared with the consortium, highlighting the importance of patient voices in shaping the project’s direction.
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June 2024
Funded by the European Union (grant agreement no. 101080243). Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
The project has also received funding from the Swiss State Secretariat for Education, Research and Innovation (SERI) and from Hungary’s National Research, Development and Innovation (NRDI) Fund.