Pharmacoepidemiology is the study of use and of the intended and unintended effects of treatments and vaccines. It is therefore a major branch of clinical epidemiology. Pharmacoepidemiology relies on various types of real-world data to generate postapproval evidence about benefit-risk profiles of treatments in broad patient populations, including subgroups of patients not represented or underrepresented in preapproval studies: elderly patients, patients with comorbidities, pregnant persons, or individuals of childbearing age.
Pharmacoepidemiology research at Department of Clinical Epidemiology is closely interwoven with all other research areas and clinical expertise. The department’s portfolio of pharmacoepidemiologic research includes regulator-mandated and voluntary studies of drug utilization, effectiveness of risk minimization measures, and pharmacovigilance studies for short-term and long-term monitoring of safety and (comparative) effectiveness, including studies in pregnancy. DCE coordinates and participates in multinational multi-database studies of treatments used for cardiovascular diseases, diabetes, osteoporosis, gastrointestinal diseases, and cancer, among others. We have, for instance, contributed important evidence into multinational studies of the safety of COVID-19 vaccines. Studies are based on routinely-collected and bespoke data from Denmark and other Nordic and European countries and apply modern principles of causal inference, including the target trial approach, directed acyclic graphs, interrupted time series, and self-controlled designs. DCE also contributes to the development of reporting guidelines for pharmacoepidemiologic studies based on routinely collected data, RECORD-PE.
Department of Clinical Epidemiology routinely participates in studies sponsored directly by the European Medicines Agency (EMA). DCE has been an active member of the EMA-run European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) and represented academia in the ENCePP Steering Group in the 2017-2019. As a member of several ENCePP working groups, DCE contributes clinical and methodological expertise to the development and maintenance of the ENCePP Standards and Guidances for pharmacoepidemiologic research.