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| 적응형 임상시험 설계× | 순차/그룹 순차 시험 설계× | |
|---|---|---|
| 분야 | 실험설계 | 실험설계 |
| 계열 | Hypothesis test | Hypothesis test |
| 기원 연도≠ | 1994 | 1979 |
| 창시자≠ | Bauer & Köhne | O'Brien & Fleming; Pocock; Lan & DeMets |
| 유형≠ | Adaptive hypothesis test with interim analyses | Adaptive stopping trial design |
| 원전≠ | Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗ | O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗ |
| 별칭≠ | adaptive design, group sequential design, sample size re-estimation, platform trial | group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential) |
| 관련 | 3 | 3 |
| 요약≠ | 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. | Sequential 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. |
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