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Thử nghiệm lâm sàng ngẫu nhiên đa trung tâm×Giai đoạn III Thử nghiệm lâm sàng×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1970s–1980s (widespread adoption for large-scale efficacy trials)1962 (Kefauver-Harris Amendment formalised phased drug development)
Người khởi xướngEvolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980sFDA regulatory framework / ICH guidelines
LoạiInterventional experimental designConfirmatory randomised controlled trial
Công trình gốcFriedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Friedman, 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 khácmulti-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trialPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
Liên quan66
Tóm tắtA multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments.A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption.
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ScholarGateSo sánh phương pháp: Multicenter Randomized Clinical Trial · Phase III clinical trial. Truy cập ngày 2026-06-19 từ https://scholargate.app/vi/compare