Periodic Reporting for period 4 - EHDEN (European Health Data and Evidence Network) Periodo di rendicontazione: 2021-11-01 al 2022-10-31 Sintesi del contesto e degli obiettivi generali del progetto Presently, Europe is generating unprecedented amounts of patient-level information contained in Electronic Health Record (EHR) systems and other types of health databases. This includes structured data in the form of diagnoses, medication, laboratory test results, etc., and unstructured data in clinical narratives, all of which likely contain invaluable insights into the natural history and burden of disease. It is our ambition to fully leverage these vast volumes of data to improve clinical practice and individual patient outcomes by increasing our understanding of disease and treatment pathways and effects. We will galvanize transparent and reproducible analytics that will generate valid real-world evidence (RWE) to improve patient care and enable medical outcomes-based research at an unprecedented scale. The European Health Data and Evidence Network (EHDEN, ehden.eu) consortium is building the infrastructure and eco-system to make this ambition come true. Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti EHDEN’s has met all deliverables and outputs with little deviation from the DoA. The project’s activity has been focused in three main pillars. Key highlights in each have been:• Open Calls: o Seven Data Partner Calls held to date, with 166 Data Partners in 26 countries from calls #1-6. Call #7 is the final call and held on the cusp of years 4 and 5 (158 applicants in 30 countries). o Four SME Calls held to date (no further calls planned), with 64 SMES selected in 22 countries, working with Data Partners at various stages of mapping to the OMOP common data model (CDM).• Infrastructure: o EHDEN Portal launched in June 2022, with free (moderated) access for researchers to explore the Data Partners and network dashboard (feasibility) of those mapped and included, with access by ~500 users internationally by end of year 4. o The Portal is being further developed with additional modules to support the study workflow into year 5. o EHDEN and OHDSI continue to collaborate (effectively symbiotic) with reference to open source tooling, skills and methods development.• Research and Outcomes: o Over the course of the project, three study-a-thons have been held by EHDEN in collaboration with OHDSI and PIONEER, and one in collaboration with UMC (in September 2022). A manuscript on the study-a-thon methodology was published in November 2022. All project publications are available via the Zenodo platform. o An Evidence Generation Taskforce was created to have oversight of evidence generation and execution from year 4 onwards, and agreement within the Consortium and IMI on the creation of an Evidence Generation Fund to support expanded activity beyond the original DoA via our two Evidence Hubs at UOXF and EMC. o As well as DoA use cases continuing in WP1, WP2 and WP3, a call for new research use cases was conducted early in year 4, and 4 were selected via the Evidence Generation Taskforce committee for inclusion into the study programme. In particular, the studies also supported engagement with Data Partners newly mapped to the OMOP CDM, and for future study-a-thons. o Extensive methodological research has been performed in the domain of personalised medicine including advances in the patient-level prediction pipeline and the assessment of risk stratified estimation, resulting in multiple publications. o A number of feasibility studies and studies proposed by third parties, including commercial, were supported by EHDEN, and coordinated network engagement via the EHDEN Community Manager and the PMO. This has served also as insightful for the future service development in sustainability post-IMI.• Education and Community: o The EHDEN Academy, launched in April 2020, has continued to flourish, with some ~3,500 enrolled by end of year 4, in nearly 70 countries worldwide, and with 17 courses launched across the tools, skills and methods spectrum, from mapping to the OMOP CDM, to working with mapped data for evidence generation. This work has also been in conjunction with the global OHDSI Education Group. o EHDEN Academy is now collaborating with HDR UK Academy, Institute for Innovation through Health Data (i~HD) and the GetReal Institute Academy in areas of mutual interest, such as co-promotion.EHDEN Communications Team have continued to establish the project as a key stakeholder in this domain, particularly as the European setting sees development of the European Commission’s European Health Data Space programme. The project has also deepened its network via communications tools, such as a monthly blog and a bi-weekly Voice of EHDEN podcast. Diverse channels have been utilised to highlight our activity, and in particular to promote our Data Partner and SME calls. EMA continued to promote EHDEN’s Data Partner calls to its distribution lists, such the ENCEPP Database. o Via WP6 and a core team, value propositions have continued to be developed and expanded for a variety of stakeholders, but also the sustainability planning for post-IMI. o A not-for-profit was incorporated in the Netherlands at the end of year 3, and the core team have further developed the sustainability plan and service thinking throughout year 4, with initial thinking around fundraising and configuration of the NFP o The Scientific and Ethics Advisory Boards are ongoing, and we have continued to consult our SAB members as relevant, whilst working on the development of a governance framework for EHDEN with our EAB. o The project has been very proactive in collaborating with the wider community with OHDSI, statutory bodies (Regulatory Authorities, Health Technology Assessment bodies, representative bodies, e.g. EFPIA, MedTech Europe, DIGITALEUROPE, et al.) and a myriad of other projects and programmes in IMI and Horizon Europe. Propagating the OMOP common data model by EHDEN has also been mirrored by wider organic adoption across countries, projects and programmes, inclusive of within IMI, further accelerating the harmonisation efforts in Europe. o We have an ongoing collaboration with OHDSI to help strengthen both our communities. Additionally, OHDSI has helped us to promote the EHDEN academy via our leadership (Project Lead) of the OHDSI Education Working Group, working on the global education strategy. Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora) Based on this fourth year’s activity and outputs, we are seeing completion of mapping to the CDM by ~50% of Data Partners mapped to the OMOP CDM by end of year 4. This mapping of Data Partners data is performed with certified SMEs, which together, will form the basis for the progenitor EHDEN network. Year 4 has seen continued, remarkable progress of the project as it transitions into a start-up phase, preparing for longer term sustainability. We have seen unprecedented responses to our Open Calls, both for Data Partners and SMEs, while generating evidence at scale, and at speed, in response to therapeutic queries. We have already demonstrated that EHDEN is making a real difference in answering critical questions for clinicians, regulatory authorities, the wider research community and above all patients. The 3 pillars in EHDEN EHDEN logo
