Prospective Observational Study
USA: FDA’s Framework for Real-World Evidence Program – A study in which the population of interest is identified at the start of the study, and exposure/treatment and outcome data are collected from that point forward. The start of the study is defined as the time the research protocol for the specific study question was initiated (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 data to be collected prospectively based on a preset research plan (as per Key Considerations in Using Real-World Evidence to Support Drug Development (Draft for Public Review) – Center for Drug Evaluation, NMPA – May, 2019)
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