Studies

The DARWIN EU® Coordination Centre implements all necessary services to generate reliable evidence from the real world data for the EU Regulatory network. DARWIN EU® provides services to EMA and the National Competent Authorities (NCAs) of the Member States. DARWIN EU® can also 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 frames 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 develops the study protocol, identifies appropriate data sources for this specific question, obtains EMA approval and executes the study with the selected data partners. Following their local governance procedures the data partners need to obtain the mandatory institutional, IRB, and/or ethics approval before running the study and sharing results. 

The data partners receives and runs the code on their own databases and provides aggregated results to the Coordination Centre. The Coordination Centre checks the quality of the study data received from each data partner and performs additional data analysis steps and interpretation. The Coordination Centre compiles the results, and is responsible to draft the study report for submission to EMA for approval. 

The studies that DARWIN EU® delivers are grouped by their anticipated level of complexity and frequency:

 

 
Category 
Description

Off-The-Shelf Studies

These are mainly characterisation questions that can be executed with a generic protocol. This includes studies on disease epidemiology, for example the estimation of the prevalence or incidence of health outcomes in defined time periods and population groups, or drug utilization studies at the population or patient level.

Complex Studies

These are studies requiring development or customisation of specific study designs, protocols, analytics and phenotypes. This includes studies on the safety and effectiveness of medicines and vaccines.

Routine Repeated Analyses

Routine analyses based on Off-The-Shelf or Complex Studies (see above), which are repeated with a pre-specified regularity (e.g. yearly)

 

Very Complex Studies

Studies which cannot rely only on electronic health care databases, or which require complex and/or novel methodological work
 
 
All studies executed by the DARWIN EU® Coordination Center are registered in the EMA-HMA Catalogue of Studies.
 
For the most up-to-date list of studies in the EMA-HMA Catalogue of Studies, search for the term DARWIN EU in the 'title of study' field. The list below is updated automatically every day with the latest ongoing and finalized studies.
 
Status Type EU PAS Register number Official Title
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