Observational studies

Observational studies are a class of study in which the patients are observed in their normal clinical setting and have not been subjected to any additional medical treatment or monitoring procedure outside of their normal clinical practice. Such studies can provide a valuable insight into the causal association between a treatment and a particular event or outcome. Although these non-experimental studies can offer greater freedom in approach to answering research questions, the lack of regulations regarding an agreed standard of conduct can also make implementing these studies challenging, particularly on a global level.

Various designs fall within this class of study including:

Patient Registries

• Cohort studies
• Case-control studies
• Cross-sectional study
• Anwendungsbeobachtung (AWB) is a type of post-marketing observational triggered by the German Drug Law (Arzneimittelgesetz (AMG))

At PACE, we have a team of pharmacoepidemiologists, pharmacovigilance, regulatory and clinical operations experts who can help you identify the best study design to meet your research objectives, the right approach to take with each of the Competent Authorities, as well as a study management and resourcing model adapted to collecting data in the most efficient manner and to agreed standards of quality.

For more information contact the PACE Group.