Post-Marketing Safety Registries

Drug safety studies often use a longitudinal cohort study design to describe drug utilization over time and characterize the risk functions of safety events of interest. Using retrospective data sources, such as medical chart reviews or electronic health care databases (e.g., claims or electronic medical records), are often a preferred approach due to the assumption they have shorter timelines and lower budgets. A post-marketing safety registry, however, uses a prospective study design to evaluate the safety of a specific drug, where patients are included if they are routinely prescribed a certain drug or group of drugs.

A safety registry enables proactive planning for possible post-marketing regulatory requirements and can generate an important added value if it is built for the right objectives in the right circumstances.

Read our white paper to find out more.