Retrospective Observational Study

Retrospective Observational Study

USA: FDA’s Framework for Real-World Evidence Program – A study that identifies the population and determines the exposure/treatment from historical data (i.e., data generated before the initiation of the study). The variables and outcomes of interest are determined at the time the study is designed (as per Framework for FDA’s Real-World Evidence Program – Glossary)

China: Key Considerations in Using Real-World Evidence to Support Drug Development – An observational study based on historical data (generated before the start of the study) (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)