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Thử nghiệm lâm sàng Giai đoạn II được khớp cặp×Thử nghiệm lâm sàng ngẫu nhiên (RCT)×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1960s–1980s (formalized with Simon optimal designs, 1989)1948 (first rigorously conducted RCT — MRC streptomycin trial)
Người khởi xướngGehan (1961) for Phase II designs; matching frameworks adapted from case-control methodologyAustin Bradford Hill; MRC Streptomycin Trial team
LoạiControlled clinical trial designInterventional experimental study
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 ↗Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
Tên gọi khácmatched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trialRCT, randomized controlled trial, randomised controlled trial, clinical randomized trial
Liên quan56
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 randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions.
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ScholarGateSo sánh phương pháp: Matched Phase II clinical trial · Randomized clinical trial. Truy cập ngày 2026-06-20 từ https://scholargate.app/vi/compare