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Thử nghiệm lâm sàng giai đoạn III kiểu Bayes×Giai đoạn III Thử nghiệm lâm sàng×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1990s–2000s (widespread application)1962 (Kefauver-Harris Amendment formalised phased drug development)
Người khởi xướngDonald A. Berry; David J. Spiegelhalter (formalization in clinical context)FDA regulatory framework / ICH guidelines
LoạiConfirmatory randomized controlled trial with Bayesian inferenceConfirmatory randomised controlled trial
Công trình gốcSpiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley. ISBN: 978-0471499756Friedman, 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 khácBayesian confirmatory trial, Bayesian RCT Phase III, Bayesian pivotal trial, BayesCTPhase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
Liên quan56
Tóm tắtA Bayesian Phase III clinical trial is a large-scale, confirmatory randomized controlled trial that uses Bayesian statistical inference rather than conventional frequentist hypothesis testing to evaluate whether an experimental treatment meets pre-defined efficacy and safety thresholds. By combining prior evidence with accumulating trial data, it quantifies the probability that the treatment effect exceeds a clinically meaningful threshold, enabling more transparent decision-making under uncertainty.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: Bayesian Phase III Clinical Trial · Phase III clinical trial. Truy cập ngày 2026-06-20 từ https://scholargate.app/vi/compare