MHRA provided an overview of the process by which research studies using electronic healthcare records, such as the Clinical Practice Research Datalink (CPRD), are conducted. This included information on how topics for study are identified, assessment of feasibility, protocol development and approval, data extraction and management and preparation of programs for analyses and subsequent interpretation. Details on the purpose of and types of studies conducted (e.g. signal evaluation, drug utilisation) were also presented. Information on employee requirements and competencies in terms of FTEs, qualifications and prior experience are provided as well. Legal requirements (e.g. data protection), compliance, inspection and quality documentation was discussed as well. Finally, triggers for particular analyses, communication on the CPRD data within and outside the MHRA, strategy for further development of the process, as well as technical development of the CPRD and policy aspects were also examined.
HALMED provided baseline analysis on available Croatian electronic healthcare data sources, data structure and organisation, legal requirements for electronic data use, prerequisites and timelines for data retrieval. This was communicated and discussed with MHRA experts in order to jointly perform gap analysis (SWOT analysis) that will help streamline further development of the process within HALMED.
During the project it was planned for HALMED to perform a case study on the safety issue relevant for HALMED using Croatian healthcare data. HALMED planned to simulate and test the process steps with real data including prioritisation and decision on the safety issue to be addressed, definition of outcomes, assessment of applicability and type of data to be used, request for data communicated to national health insurance fund, data analysis, statistical analysis, interpretation and communication of results. Process steps were planned to be supervised by MHRA with corrections and suggestions to be provided based on their experience in all phases of the process.
Initial project timelines have been delayed by the late start of the twinning. For meeting the previously set timelines, task 3 has been adapted: HALMED re-used one of the studies done by MHRA and adapted the study protocol according to the available Croatian data taking into account its structure and availability.
Based on the results of the gap analysis and the case study HALMED developed a concept and plan for the implementation of a process for electronic data analysis into HALMED’s routine practice of drug safety monitoring. An internal (HALMED) strategic document was developed, including plan for capacity building, as well as communication strategy to stakeholders outside HALMED in order to highlight and explain the importance of such processes and to ensure the sustainability of the project results.