Cohort studies

In a pharmaceutical cohort study the effect of drug exposure on the occurrence of adverse events and illnesses is examined. For this purpose, either the temporal development of certain characteristics in a group of exposed persons is studied (intra-cohort comparison), or two cohorts – a group of exposed and a group of non-exposed persons – are observed over a certain period (Inter-cohort comparison).

In a prospective cohort design, which is the most common, the cohort is put together in the presence and accompanied to the future. If data is sourced from the past for the evaluation of the study, it is called a retrospective cohort study. At the end of the observation period, a relation or non-relation to the drug therapy can be seen by determining and comparing the number of adverse events (incidence) in exposed and non-exposed persons. Cohort studies are well suited for the determination of the occurrence and the frequency of rare adverse events or to investigate long-term effects of the product under certain conditions.

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