方法对比
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| 顺序/分组顺序试验设计× | 自适应临床试验设计× | |
|---|---|---|
| 领域 | 实验设计 | 实验设计 |
| 方法族 | Hypothesis test | Hypothesis test |
| 起源年份≠ | 1979 | 1994 |
| 提出者≠ | O'Brien & Fleming; Pocock; Lan & DeMets | Bauer & Köhne |
| 类型≠ | Adaptive stopping trial design | Adaptive hypothesis test with interim analyses |
| 开创性文献≠ | O'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 ↗ |
| 别名≠ | group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential) | adaptive design, group sequential design, sample size re-estimation, platform trial |
| 相关 | 3 | 3 |
| 摘要≠ | 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. | 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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