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순차/그룹 순차 시험 설계×적응형 임상시험 설계×
분야실험설계실험설계
계열Hypothesis testHypothesis test
기원 연도19791994
창시자O'Brien & Fleming; Pocock; Lan & DeMetsBauer & Köhne
유형Adaptive stopping trial designAdaptive hypothesis test with interim analyses
원전O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗
별칭group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential)adaptive design, group sequential design, sample size re-estimation, platform trial
관련33
요약Sequential and group sequential trial designs allow a study to be stopped early — or continued — based on interim analyses conducted as data accumulate. The core framework was formalised by O'Brien and Fleming in 1979 and extended by Lan and DeMets's alpha-spending approach, and it controls the overall Type I error rate across all planned looks by pre-specifying both efficacy and futility boundaries before enrolment begins.Adaptive clinical trial design is a flexible experimental framework, formalised by Bauer and Köhne in 1994, in which pre-specified rules allow the trial to be modified mid-course — adjusting sample size, treatment arms, or randomisation ratios — based on accumulating interim data while rigorously controlling the Type I error rate.
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