Studies
The DARWIN EU® Coordination Centre implements all necessary services to generate reliable evidence from the real world data for the EU Regulatory network. Initially DARWIN EU® will provide services to EMA and the National Competent Authorities (NCAs) of the Member States. As the network expands, DARWIN EU® may perform studies requested by EMA on behalf of third parties such as other EU level health agencies (e.g. European Centre for Disease Prevention and Control (ECDC), health technology assessment bodies or payers.
For questions raised by a partner from the EU Regulatory Network and requiring additional evidence to support regulatory decision-making, EMA will frame a research question and evaluate, in consultation with the Coordination Centre, the relevance and feasibility of interrogating the network. For each study, the Coordination Centre will develop the study protocol, identify appropriate data sources for this specific question, obtain EMA approval and perform the conduct of the study with data partners. Following their local governance procedures the data partners need to obtain the mandatory institutional, IRB, and/or ethics approval.
The data partners will receive and run the code on their own databases and provide aggregated results to the Coordination Centre. The Coordination Centre will check the quality of the study data received from each data partner and perform additional data analysis steps and interpretation. The Coordination Centre will compile the results, will be responsible to draft the study report and to submit the report to EMA for approval.
The studies that DARWIN EU® will deliver are grouped by their anticipated level of complexity and frequency: