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다기관 임상 3상 시험×베이지안 무작위 임상시험×
분야역학역학
계열Process / pipelineProcess / pipeline
기원 연도1940s–1990s (formalized through ICH harmonization ~1990s)1980s–2000s (formal methodology consolidated ~2004–2006)
창시자Codified 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)
유형Confirmatory interventional study designRandomized experimental study with Bayesian inference
원전Friedman, 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
별칭Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trialBayesian RCT, Bayesian adaptive trial, Bayesian clinical trial design, BRCT
관련65
요약A 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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ScholarGate방법 비교: Multicenter Phase III Clinical Trial · Bayesian Randomized Clinical Trial. 2026-06-19에 다음에서 검색함: https://scholargate.app/ko/compare