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Thử nghiệm lâm sàng đa trung tâm Giai đoạn III×Thử nghiệm lâm sàng ngẫu nhiên kiểu Bayes×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1940s–1990s (formalized through ICH harmonization ~1990s)1980s–2000s (formal methodology consolidated ~2004–2006)
Người khởi xướngCodified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA)Donald A. Berry and David J. Spiegelhalter (applied Bayesian inference formally to RCT design)
LoạiConfirmatory interventional study designRandomized experimental study with Bayesian inference
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: 978-3319185385Spiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley. ISBN: 978-0471499756
Tên gọi khácPhase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trialBayesian RCT, Bayesian adaptive trial, Bayesian clinical trial design, BRCT
Liên quan65
Tóm tắtA multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites.A Bayesian randomized clinical trial (Bayesian RCT) combines the rigour of random treatment allocation with Bayesian statistical inference, allowing researchers to incorporate prior evidence and update beliefs continuously as trial data accumulate. Unlike the classical frequentist RCT, it yields direct probability statements about treatment effects and supports pre-specified adaptive stopping rules based on posterior probabilities.
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ScholarGateSo sánh phương pháp: Multicenter Phase III Clinical Trial · Bayesian Randomized Clinical Trial. Truy cập ngày 2026-06-19 từ https://scholargate.app/vi/compare