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Nghiên cứu Giai đoạn IV Đối sánh×Nghiên cứu thuần tập×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1980s–1990s (formalized in post-marketing regulatory frameworks)Mid-20th century (formal epidemiological design codified ~1950s)
Người khởi xướngRegulatory tradition (FDA, EMA); matching methodology from Rosenbaum & Rubin (1983)Doll & Hill (British Doctors Study, 1951); Snow (cholera, 1854)
LoạiObservational study designObservational longitudinal study design
Công trình gốcStrom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. Wiley. ISBN: 978-0470029244Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
Tên gọi khácmatched post-marketing surveillance study, Phase IV matched cohort study, matched pharmacoepidemiological study, post-authorization matched safety studylongitudinal study, follow-up study, panel study, incidence study
Liên quan56
Tóm tắtA Matched Phase IV study is a post-marketing observational design in which patients who received an approved drug (or intervention) are matched to comparable non-exposed patients — or patients on an alternative therapy — to evaluate real-world safety, effectiveness, or long-term outcomes. Conducted after regulatory approval, it combines the epidemiological rigour of matching with the breadth of post-authorization pharmacovigilance, generating evidence that randomized trials are rarely powered or timed to provide.A cohort study assembles a group of individuals who share a common starting point — typically freedom from the outcome of interest — and follows them over time to observe who develops the outcome. By comparing incidence rates between exposed and unexposed subgroups, researchers can estimate relative risk and absolute risk differences. Cohort studies are the gold-standard observational design for measuring disease incidence and establishing temporal relationships between exposure and outcome.
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ScholarGateSo sánh phương pháp: Matched Phase IV Study · Cohort Study. Truy cập ngày 2026-06-17 từ https://scholargate.app/vi/compare