Rezultaty
This deliverable will provide an update on the analytical pipeline for patient-level prediction and risk effect estimation. Moreover, it will contain results of proof-of-concept studies in these domains.
Report on educational and training material for the developed analytical tools (1)Report on the training materials that have been developed and a status on the delivery to the different target audiences (SME's, researchers, hospitals and GPs, registries and biobanks etc.).
Yearly Progress report on technical framework (4)A description of the progress on the technical platform and outlook for the following 12 months.
Yearly Progress report on technical framework (2)A description of the progress on the technical platform and outlook for the following 12 months.
Selected priority therapeutic areasA short report on the completion of task 2.1
Final version of the Framework for quality benchmarkingThis deliverable will offer the comprehensive framework.
Yearly Progress report on technical framework (1)A description of the progress on the technical platform and outlook for the following 12 months.
Report on key data source/s of interest for WP1 Use CasesThis report will provide the rationale for mapping different types of data as relevant for the proposed use cases.
First Report on educational and training material for the developed analytical toolsThis deliverable will provide an update on the creation of educational and training material for the analytical tools developed in this work package.
"Results of ""validation"" Use Case 1 study"A validation study, replicating analyses on RMM Effectiveness (Use Case 1) using unmapped as well as OMOP-mapped data will be conducted. A report with its results will be delivered by the end of Month 37.
Results of first Use Case 2 studyA report with results from the first proof-of-concept drug/device safety study will be submitted by Month 53
Results of Use Case 3 studyThe results of Use Case 3 studies will be reported by Month 48.
Report on Federated Network Studies (1)These deliverables will update on the deployment of the study execution pipeline in the context of the Use Case in WP1-3 and possibly for other stakeholders later in the project.
Ethics Advisory Board nominationNomination of the Ethics Advisory Board pursuant to the Ethics Review
Report on liaison with other BD4BO projectsThis deliverable will report on the relationship and collaborations established with other BD4BO projects, with an evaluation of results obtained and impact.
Selection of use cases for personalized medicineWe will perform a survey including all the stakeholders to develop a list to use cases for the personalized medicine pipeline. This will include prediction and risk effect estimation use cases.
Workshop for HTA and payer community: demonstrate the OMOP-CDM for generating meaningful HTA + payer evidence (2)Short workshop report of the second workshop (task 2.5)
Third Report on the implementation of the analytical pipeline for personalized medicineThis deliverable will provide an update on the analytical pipeline, including the disease trajectory pipeline.
First Report on the implementation of selected use cases in the data networkThis report describes the progress made on testing the analytical pipelines in the data network.
First report on community buildingThis deliverable will report the results of deployment of outreach activities in terms of stakeholders (both institutions and professionals) successfully involved in EHDEN and established working dynamics, describing gaps and areas that should be reinforced according to the evolution of the field.
ICHOM standards defined using OMOP terminologyThis deliverable provides insight on how the prioritized ICHOM standard sets as defined in D2.1 can be implemented using the OMOP-CDM.
Analysis of potential Public-Private Partnership exploitation modelsThis deliverable will analyse both successful and unsuccessful exploitation models used by initiatives similar to EHDEN, studying their application domain and their potential to serve as blueprint for EHDEN sustainability.
Roadmap for interoperability solutionsDescription of the process for and technology applied for interoperability with other 'standard' platforms.
Workshop for HTA and payer community: demonstrate the OMOP-CDM for generating meaningful HTA + payer evidenceShort workshop report of the first workshop (task 2.5)
Report on SME Certification Procedure and Data Source Grant Awarding Procedure developed and implementedReport on SME Certification Procedure and Data Source Grant Awarding Procedure developed and implemented. This will include the Open Call announcement text and instructions for applicants, definition of selection and evaluation committees and description of eligibility criteria.
Stakeholder mappingThis deliverable will report on the different stakeholder types that will need a value proposition for successful outreach, including if necessary sub-categories.
Report on Federated Network Studies (2)These deliverables will update on the deployment of the study execution pipeline in the context of the Use Case in WP1-3 and possibly for other stakeholders.
Final Report on the implementation of the analytical pipeline for personalized medicineThis deliverable will provide an update on the analytical pipeline, including the disease trajectory pipeline
First Report on the implementation of the analytical pipeline for personalized medicineThis deliverable will provide an update on the analytical pipeline for patient-level prediction and risk effect estimation
First version of the Framework for quality benchmarkingThis deliverable will contain the description of the quality management and control framework with a primary focus on the mapping process, also incorporating stakeholder consultations.
Report on Quality Assurance and Control ProceduresThis report discusses the implementation of the quality assurance and control procedures for the full eco-system.
Yearly Progress report on technical framework (3)A description of the progress on the technical platform and outlook for the following 12 months
Technical framework design and architectureThe identification of the individual components, the functional and technical integration of these components in the EHDEN platform are the subject of this first deliverable.
Assessment of regulatory requirements for patient-level decision makingReport on the mapping of regulatory requirements across Europe for risk prediction models.
Tools for interrupted time series analyses will be integrated and fully accessible as part of the EHDEN toolkit.
OMOP-CDM enhancements for Outcome Driven HealthcareThis deliverable describes the changes needed in the OMOP-CDM to capture the information for the ICHOM standard sets and Patient Reported Outcomes in general. This includes structural changes as well as changes to the Standardized Vocabularies.
We will provide online training materials for researchers to conduct ITS analyses within the EHDEN ecosystem.
Publikacje
Autorzy:
Gauffin, Oskar; Brand, Judith S.; Hedfors Vidlin, Sara; Sartori, Daniele; Asikainen, Suvi; Català, Martí; Chalabi, Etir; Dedman, Daniel; Danilovic, Ana; Duarte-Salles, Talita; García Morales, Maria Teresa; Hiltunen, Saara; Jödicke, Annika M.; Lazarevic, Milan; Mayer, Miguel A.; Miladinovic, Jelena; Mitchell, Joseph; Pistillo, Andrea; Ramírez-Anguita, Juan Manuel; Reyes, Carlen; Rudolph, Annet
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Opublikowane w:
J Am Med Inform Assoc, 2023, ISSN 1527-974X
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Oxford University Press
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10.1093/jamia/ocad160
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Nature Communications, 2021, ISSN 2041-1723
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