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:

 

 

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  European Union electronic Register of Post-Authorisation Studies (EU PAS Register).
 
For the most up-to-date list of studies, search for the term DARWIN EU in the 'title of study' field. The list below will be updated on a monthly basis.
 
Status Type EU PAS Register number Official Title Last Updated
Finalised off-the-shelf EUPAS50789 DARWIN EU® Drug utilisation of valproate-containing medicinal products in women of childbearing potential 21/03/2024
Finalised off-the-shelf EUPAS103381 DARWIN EU® DUS of Antibiotics in the ‘Watch’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use 21/03/2024
Finalised complex EUPAS103936 DARWIN EU® Background rates of serious adverse events to contextualise safety assessments in clinical trials and non-interventional studies in adolescent and adult patients with severe asthma. 21/03/2024
Finalised off-the-shelf EUPAS50800 DARWIN EU® Prevalence of rare blood cancers in Europe 21/03/2024
Finalised off-the-shelf EUPAS105033 DARWIN EU® Multiple myeloma: patient characterisation, treatments and survival in the period 2012-2022 21/03/2024
Finalised off-the-shelf EUPAS105641 DARWIN EU® Drug utilization study of prescription opioids 21/03/2024
Ongoing complex EUPAS106679 DARWIN EU® EHDS Use Case: Natural history of coagulopathy in COVID-19 patients and persons vaccinated against SARS-CoV-2 in the context of the OMICRON variant 06/03/2024
Finalised off-the-shelf EUPAS106052 DARWIN EU® Co-prescribing of endothelin receptor antagonists (ERAs) and phosphodiesterate-5 inhibitors (PDE-5is) in pulmonary arterial hypertension (PAH) 06/03/2024
Finalised off-the-shelf EUPAS105644 DARWIN EU® Use of take-home naloxone for opioid overdose treatment 21/03/2024
Finalised off-the-shelf EUPAS106798 DARWIN EU® Drug utilisation study of medicines with prokinetic properties in children and adults diagnosed with gastroparesis 21/03/2024
Finalised off-the-shelf EUPAS106436 DARWIN EU® Treatment patterns of drugs used in adult and paediatric population with systemic lupus erythematosus 21/03/2024
Ongoing off-the-shelf EUPAS106685 DARWIN EU® Rates of occurrence of treatment-related intercurrent events in patients with major depressive disorder 21/03/2024
Finalised off-the-shelf EUPAS107708 DARWIN EU® Age specific incidence rates of RSV related disease in Europe 21/03/2024
Finalised off-the-shelf EUPAS107650 DARWIN EU® Characterization of patients with chronic hepatitis B and C 21/03/2024
Ongoing Complex EUPAS107615 DARWIN EU® Effectiveness of COVID 19 vaccines on severe COVID 19 and post acute outcomes of SARS CoV 2 infection 21/03/2024
Finalised off-the-shelf EUPAS107454 DARWIN EU® Natural history of dermatomyositis (DM) and polymyositis (PM) in adults and paediatric populations 21/03/2024
Ongoing off-the-shelf EUPAS107932 DARWIN EU® Monitoring prescription of medicines for public health emergencies at risk of shortages 21/03/2024
Ongoing off-the-shelf EUPAS1000000088 DARWIN EU® Direct and indirect prevalence estimation 27/05/2024
Ongoing off-the-shelf EUPAS1000000089 DARWIN EU® Monitoring prescription of essential medicines administered in ICU 27/05/2024
Ongoing off-the-shelf EUPAS1000000112 DARWIN EU® Overall survival in patients with advanced or metastatic non-small cell lung cancer treated with selected immunotherapies as first line of treatment 27/05/2024
Ongoing off-the-shelf EUPAS1000000080 DARWIN EU® Effectiveness of Human Papillomavirus Vaccines (HPV) to prevent cervical cancer in women 27/05/2024
Ongoing off-the-shelf EUPAS1000000150 DARWIN EU® Drug utilisation study on medicinal use of Pelargonii radix 27/05/2024
Ongoing off-the-shelf EUPAS1000000162 DARWIN EU® Current lines of treatment and overall survival in patients with chondrosarcoma 27/05/2024
Ongoing off-the-shelf EUPAS1000000172 DARWIN EU® Characterising Interstitial Lung Disease in Europe 27/05/2024