What is an observational study?
Observational studies collect and analyze data on patients in real-world settings without assigning specific treatments. These studies may be prospective or retrospective and often use sources such as electronic health records, registries, or claims databases. They are used to study effectiveness, safety, healthcare utilization, and disease burden.
Why are observational studies important in evidence generation?
They provide insights that complement clinical trials by reflecting real-world practice, patient variability, and long-term outcomes. Observational data are increasingly used in regulatory and HTA submissions and play a key role in stakeholder engagement and market access strategy.
