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Thử nghiệm lâm sàng Giai đoạn II được khớp cặp×Nghiên cứu bệnh-chứng bắt cặp×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1960s–1980s (formalized with Simon optimal designs, 1989)1950s–1970s
Người khởi xướngGehan (1961) for Phase II designs; matching frameworks adapted from case-control methodologyBrian MacMahon and others; systematised by Schlesselman (1982)
LoạiControlled clinical trial designObservational analytic design
Công trình gốcGehan, E. A. (1961). The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases, 13(4), 346–353. DOI ↗Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755474
Tên gọi khácmatched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trialmatched case-referent study, individually matched case-control, pair-matched case-control, matched case-control design
Liên quan55
Tóm tắtA matched Phase II clinical trial is a single-arm or small-controlled early-efficacy study in which treated patients are paired with matched controls — drawn from historical databases, registries, or concurrent external cohorts — on key prognostic variables such as age, disease stage, and performance status. This design allows preliminary efficacy assessment without a concurrent randomized arm, trading randomization for feasibility while partially controlling for confounding through the matching process.A matched case-control study is an observational epidemiological design in which each case (a person with the disease or outcome of interest) is paired with one or more controls (persons without the outcome) who share one or more characteristics — such as age, sex, or clinical setting — to control confounding. Exposure history is then compared between cases and their matched controls to estimate the odds ratio of the exposure-disease association.
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ScholarGateSo sánh phương pháp: Matched Phase II clinical trial · Matched case-control study. Truy cập ngày 2026-06-18 từ https://scholargate.app/vi/compare