Observational Studies

Observational Studies

USA: FDA’s Framework for Real-World Evidence Program – A non-interventional clinical study design that is not considered a clinical trial (as per Framework for FDA’s Real-World Evidence Program – Glossary)

USA: clinicaltrials.gov – A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.  A patient registry is a type of observational study (as per clinicaltrials.gov Glossary)

China: Key Considerations in Using Real-World Evidence to Support Drug Development – A study that explores the outcomes in natural or clinical populations without active intervention, based on specific research objectives (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)