Institution identification

PURI

https://redirect.ema.europa.eu/resource/42185

Institution ID

42185

Institution full name and acronym

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Institution countries

Denmark

Type of institution

Educational Institution

Institution role

Researcher

Institution website

ENCePP partner

Yes
Institution description
Department of Clinical Epidemiology (DCE) is a large academic department affiliated at Aarhus University Hospital and belongs under Institute of Clinical Medicine at Aarhus University (Denmark). Clinicians at the department have expertise in all major clinical areas. Researchers in the department use modern epidemiological methods to study disease occurrence, risk factors, prognosis, and safety of treatments and vaccines. The available expertise includes triangulation, target trial emulation, use of common data models with distributed networks, data management and programming using SAS and R. The department is engaged in a variety of activities including supervision, teaching research, consulting, and improvement of the quality of care and treatment offered to patients. Pharmacoepidemiology is one of the department's research priorities and areas of expertise, and researchers from DCE have held leading posts in the ENCePP and ISPE. The department is a pioneer of using real-world data for epidemiologic research, with more than 20 years experience. It routinely conducts and coordinates multinational epidemiologic studies based on primary and secondary data. The department's research output is more than 200 publications per year.
Institution details
Experience with collecting data directly from individual patients or respondents:
Yes
Interest in carrying out research that is funded by pharmaceutical companies:
Yes

Contact

Studies conducted by the institution

A multinational active safety surveillance study of crizotinib in Europe and the United States
A non-interventional study to examine patient characteristics and drug utilization patterns in migraine patients treated with prophylactic drugs in Nordic countries
A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes
A Population-based Study of the Safety of Gabapentin Use During Pregnancy
ACCESS template protocol for safety of COVID-19 vaccines
Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens
Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark, Norway, Sweden))
CharacTeristics of treAtment response to hIgh dose ICS/LABA vs. Medium or high dOse ICS/LABA + LAMA in patients with uncontRolled moderate to severe asthma on medium dose ICS/LABA - TAILOR study
Cohort study of cardiovascular events in patients with chronic obstructive pulmonary disease initiating olodaterol or other long-acting beta2-agonists
Cohort Study of Long-term Safety of Upadacitinib for the Treatment of Ulcerative Colitis and Crohn’s Disease in a Real-world Setting in Europe
Cohort Study of Long-term Safety of Upadacitinib in the Treatment of Atopic Dermatitis in Denmark and Sweden
Comparative Cohort Study of Long-term Safety Outcomes of Risankizumab Compared to Biologic Treatments for Crohn’s Disease in a Real-world Setting in Sweden and Denmark
Description of international collaboration in the area of medicines use and effects in COVID-19 affected pregnancies (CONSIGN-International))
Drug Utilisation Study for Olodaterol
Drug utilisation study of Radium 223 under routine clinical practice in Europe (DIRECT)
Drug utilisation study of upadacitinib (Rinvoq™) in Europe to evaluate the effectiveness of additional risk minimisation measures
Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe
Drug Utilization Study Evaluating Additional Risk Minimization Measures for Upadacitinib in the Treatment of Atopic Dermatitis in Europe
Estimating prevalence and incidence of acute myocardial infarction in a set of heterogeneous sources of observational health data collaborating in the EMIF Platform
EUROPEAN NON-INTERVENTIONAL POST AUTHORIZATION SAFETY STUDY RELATED TO SERIOUS INFECTIONS FOR ROMOSOZUMAB BY THE EU ADR ALLIANCE
EUROPEAN NON-INTERVENTIONAL POST-AUTHORIZATION SAFETY STUDY RELATED TO ADHERENCE TO THE RISK MINIMIZATION MEASURES FOR ROMOSOZUMAB BY THE EU-ADR ALLIANCE
European non-interventional post-authorization safety study related to serious cardiovascular events of myocardial infarction and stroke, and all-cause mortality for romosozumab by the EU-ADR Alliance
European Program of Post-Authorization Safety Studies for Protelos®/Osseor® through EU-ADR Alliance
Exposure and coverage to routine schedule vaccines in different EU countries (ADVANCE-POC2)
FINErenone druG Utilization Study and assessment of Temporal changes following availability of different treatment options in patients with chronic kidney disease and type 2 diabetes (FINEGUST)
Impact of risk minimisation in patients treated with rosiglitazone-containing products
Intravenous Iron Postauthorisation Safety Study (PASS): Evaluation of the Risk of Severe Hypersensitivity Reactions
Long-term comparative safety cohort studies of upadacitinib (Rinvoq™) use for the treatment of RA in Europe
Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) (MALBEC-f)
Metformin use in renal impairment
Monitoring safety of Spikevax in pregnancy: an observational study using routinely collected health data in five European countries (COVID-19)
Monitoring the effectiveness of risk minimisation in patients treated with pioglitazone-containing products
mRNA-1273-P910: Clinical course, outcomes and risk factors of myocarditis and pericarditis following administration of Moderna vaccines targeting SARS-CoV-2.
Multinational database cohort study to assess RMP specified safety outcomes in association with indacaterol/glycopyrronium bromide in Europe
Multinational, multi-database cohort study to assess adverse cardiovascular and cerebrovascular outcomes and mortality in association with inhaled NVA237 in Europe (NVA237 PASS)
Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis (MELODIC Study)
Post-Authorisation Safety Study (PASS) of the Utilisation Patterns of Apixaban in Denmark
Post-Authorization Active Surveillance Safety Study Using Secondary Data to Monitor Real-World Safety of Spikevax in Europe (COVID-19)
Postauthorisation Safety Study (PASS) of Avatrombopag and Haematological Malignancies in Patients With Primary Immune Thrombocytopaenia
Renin-angiotensin-aldosterone system inhibitors and adverse outcomes of COVID-19: a Danish nationwide cohort study (ACE-I/ARB and COVID-19)
SAFETY-VAC: a framework for the post-authorisation safety monitoring and evaluation of vaccines in the European Union (SAFETY-VAC)
SAFETY-VAC: Background incidence estimation of flares of pre-existing chronic diseases using pan-European electronic healthcare data sources. (SAFETY VAC)
Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism
Study of utilisation of combined hormonal contraceptives in Europe
Use cases for development, optimisation and implementation of artificial intelligence methods for real world data analyses in regulatory decision-making and health technology assessment along the product lifecycle (Real4Reg)
Use of Bone Marrow Biopsies in Patients With Chronic Immune Thrombocytopenia: Predictors For, And Prognosis After – a Nordic Population-based Cohort Study And a Nested Case Control Study
Xarelto Paediatric VTE PASS Drug Utilization Study: An observational, longitudinal, multi-source drug utilization safety study to evaluate the drug use patterns and safety of rivaroxaban oral suspension in children under two years with venous thromboembolism (XAPAEDUS)