Periodic Reporting for period 1 - INTEGRATE-LMedC (Concept development for a research infrastructure to manage, integrate and sustain large medical cohort studies)
Okres sprawozdawczy: 2024-01-01 do 2025-06-30
The INTEGRATE-LMedC consortium is developing a new concept to guide and support decision-making for the next-generation research infrastructure (RI) to facilitate efficient utilization and harmonization of large medical cohorts (LMedC), and to accelerate scientific and medical breakthroughs in Europe and beyond. Our ambitious objectives are only possible through the integration of 11 highly interdisciplinary partners including established ERIC / ESFRI infrastructures such BBMRI, ECRIN, EIRENE and EBRAINS with unique expertise in conceptualizing and implementing European RIs. The partners have generated a gap analysis to identify what is missing of cohort data and samples, RI tools and services, quality measures, governance models, user needs and the barriers for efficient utilization of these cohorts and RI, including ethical and legal frameworks. We have identified IT technologies and architecture for suitable data stewardship and long-term availability of European RIs implemented in the concept and feasibility of two use-cases: one stroke case using data from medical health registry data and one case using data from longitudinal population-based studies with different technical, legal, and ethical challenges.
To ensure availability of data and samples related to existing and future LMedC studies and their re-use for secondary research, the partners have developed a concept outline including a governance plan and guiding principles for data access policies and data protection policy, whilst considering the FAIR principles and ELSI issues. Finally, an overarching RI concept to manage, integrate, and sustain LMedC studies will be developed, including an initial financial and operational plan for the implementation of the new RI outlining new services and access opportunities for the research community.
To ensure availability of data and samples related to existing and future LMedC studies and their re-use for secondary research, the partners have developed a concept outline including a governance plan and guiding principles for data access policies and data protection policy, whilst considering the FAIR principles and ELSI issues. Finally, an overarching RI concept to manage, integrate, and sustain LMedC studies will be developed, including an initial financial and operational plan for the implementation of the new RI outlining new services and access opportunities for the research community.
Through Deliverable 3.1 “Outcomes of the gap analysis of large medical cohorts,” we have established a formal definition of LMedC and mapped the current European landscape of cohorts and research infrastructures. A Delphi study identified key gaps in depression, Alzheimer’s disease and other dementias, and endometriosis, while a scoping review highlighted existing cohorts in these areas. Experts pointed to lack of data quality, comparability, and reluctance to share data as major barriers, recommending the creation of a dedicated research infrastructure. In WP4, we mapped available infrastructure services across the research-data lifecycle, based on surveys and interviews with 25 organisations, revealing strong capacities in areas such as data services, biobanking, and ethics, but also a fragmented landscape with limited full-spectrum coverage. This work informs coordination, scaling of services, and EU investment, and contributes directly to policy discussions on the EHDS, EOSC, and ESFRI roadmaps. Deliverable 6.1 introduced guidelines for assessing LMedC suitability for inclusion in future infrastructures, considering ELSI and FAIR principles, while Deliverable 6.2 reviewed strategies for engaging participants, researchers, and cohort managers, offering recommendations on incentives and stakeholder involvement. Deliverable 9.1 analysed stewardship and data sharing models, mapping ethical, legal, and IT requirements and recommending specific technologies for data discovery (BBMRI-ERIC directory/locator, DataShield), access negotiation (BBMRI-ERIC negotiator), and analysis (DataShield), to be further developed in connection with EOSC and EHDS. Finally, Deliverable 11.1 presented the first version of the clinical cohort catalogue, populated with 68 cohorts from UMCG, and defined next steps for expanding its scope and improving the underlying software.
INTEGRATE-LMedC is pushing the boundaries of what is currently possible, which includes enhanced solutions for data handling, data sharing and data labs (WP9). The project will expand the infrastructure scope and capacity by the addition of new capabilities and expansion of the infrastructure's user base to include previously underserved research communities and the establishment of new modes of operation and services. This involves the implementation of novel approaches to data management or user engagement, such as the use of open science principles or the development of new user interfaces and tools.
The INTEGRATE-LMedC project has delivered results across two complementary pillars, each with potential for significant scientific and societal impact. Pillar 1 focused on gap analysis, and in RP1 producing comprehensive reports to guide future decision-making and research priorities (WP3), ethical, legal and societal (ELSI) considerations, and FAIR-aligned data practices (WP6). Pillar 2, encompassing IT technologies and architecture and data sharing models (WP9), information security measures (WP10), as well as a FAIR-compliant online catalogue documenting the landscape of large medical cohorts. In addition, pilot efforts harmonised selected European strategic cohorts (WP11) demonstrating integrated data analyses (WP12), underpinning a feasibility study to support scalable implementation (for RP2).
The INTEGRATE-LMedC project has delivered results across two complementary pillars, each with potential for significant scientific and societal impact. Pillar 1 focused on gap analysis, and in RP1 producing comprehensive reports to guide future decision-making and research priorities (WP3), ethical, legal and societal (ELSI) considerations, and FAIR-aligned data practices (WP6). Pillar 2, encompassing IT technologies and architecture and data sharing models (WP9), information security measures (WP10), as well as a FAIR-compliant online catalogue documenting the landscape of large medical cohorts. In addition, pilot efforts harmonised selected European strategic cohorts (WP11) demonstrating integrated data analyses (WP12), underpinning a feasibility study to support scalable implementation (for RP2).