Demonstrate the functionality of the tools and services provided by Work Packages 3-6 and to evaluate the EHR4CR platform in terms of clinical study design and execution with a specific focus towards a set of mutually acceptable medical domains agreed between the pilot sites and the EFPIA partners
Pilots evaluations will occur at several large academic hospitals, interfacing with EHR systems, with a specific focus towards a set of mutually agreed medical domains between the pilot sites and EFPIA partners (e.g. Diabetes, Oncology).
Example of tasks
Develop Interfaces between local EHR/CDW and CDMS systems and the uniform access layer
Execute pilots on Protocol Feasibility, Patient Recruitment, Clinical Trial Execution, Drug Safety Monitoring)
Inventory of local data sources and the matching of EFPIA clinical studies with suitable clinical data providers.
Clinical Trial Feasibility (Task 7.2)
Year 1: The inventory of data sources will be established and data schemes as well as data quality will be described. This information will be matched with EFPIA's analysis of clinical studies, in particular with respect to inclusion and exclusion criteria, in order to select suitable pilot studies.
Year 2: The ability of the EHR4CR platform to provide feasibility information for the previously selected study scenarios will be demonstrated. It will be assessed how the flexibility of the platform to modify inclusion and exclusion criteria and thus identify more suitable patients will result in an optimized trial design.
Year 3: Comparison of feasibility information based on the EHR4CR platform with conventional methods regarding precision and efficiency will be performed.
Year 4: Further improvement of the efficiency of the trial feasibility demonstrators based on EFPIA evaluation (based on evaluation concept from work package 1).
WP 8 Communication and Dissemination Activities, Liaison and
Support the communication and training between all EHR4CR Work Package Groups and Work Packages and promote EHR4CR services to prepare for EHR4CR platform exploitation
Widely disseminate the EHR4CR outcomes and communicate with other EC FP or IMI projects in Europe and globally.
WP 9 Management
Coordinate the work of the EHR4CR project, administer day-to-day operations, manage the collaborative efforts of the Work Packages
Ensure that the scientific work being conducted is delivered on time and on budgets through optimal project management, including quality monitoring, planning, reporting and financial control.
Example of tasks
Project Website development and maintenance, Project collaboration space
Dissemination and liaison activities in EU
Coordination and managing of IMI JU funding, Project management office