Pharmacoepidemiological studies examine the use of medications in populations of interest (including any effects from their use such as adverse drug reactions). Such studies can be used to:
- define disease burden in terms of prevalence, incidence, cost, disability and potential complications
- examine patient characteristics and drug utilisation
- examine outcomes including the safety of medicines
In post-marketing, pharmacoepidemiological studies can be used to:
- examine drug utilisation in real life settings in special populations, including off-label use, misuse and medication errors
- examine potential risks, identified risks and missing information as outlined in a product’s Risk Management Plan
- study the overall safety profile of a medicinal product
- examine safety signals identified from spontaneous reporting or other sources
Our multidisciplinary team of epidemiologists, statisticians, clinicians and research scientists can design studies to fit regulatory requirements, ensuring that they meet our high standards. We are experienced with the application of a wide range of pharmacoepidemiological methods and can advise on all aspects of study design and analysis including survival techniques and self-controlled designs using a broad range of data sources (internal DSRU sources as well as other sources across Europe).
The publications listed below provide just a snapshot of our pharmacoepidemiological experience. However to appreciate the breadth of our capabilities, please contact us for an informal discussion.