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Nghiên cứu Giai đoạn IV Đối sánh×Thiết kế Nghiên cứu Trường hợp-Đối chứng×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1980s–1990s (formalized in post-marketing regulatory frameworks)1950s (formal methodology); precursors in the 1920s
Người khởi xướngRegulatory tradition (FDA, EMA); matching methodology from Rosenbaum & Rubin (1983)Janet Lane-Claypon (early precursors, 1926); formalized by Brian MacMahon and Jerome Cornfield in the 1950s–1960s
LoạiObservational study designObservational analytic study design
Công trình gốcStrom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. Wiley. ISBN: 978-0470029244Schlesselman, J.J. (1982). Case-Control Studies: Design, Conduct, Analysis. Oxford University Press. ISBN: 978-0195027860
Tên gọi khácmatched post-marketing surveillance study, Phase IV matched cohort study, matched pharmacoepidemiological study, post-authorization matched safety studycase-referent study, case-control design, retrospective case-control, case-control analysis
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 case-control study is a retrospective observational design in which individuals who have developed a disease or outcome of interest (cases) are compared with individuals who have not (controls) to determine whether prior exposure to a putative risk factor differs between the two groups. The primary measure of association is the odds ratio, which approximates the relative risk when the outcome is rare. Case-control studies are especially efficient for investigating rare diseases and generating etiological hypotheses.
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ScholarGateSo sánh phương pháp: Matched Phase IV Study · Case-control study. Truy cập ngày 2026-06-15 từ https://scholargate.app/vi/compare