方法对比
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| 自适应I期临床试验× | 自适应临床试验设计× | |
|---|---|---|
| 领域≠ | 流行病学 | 实验设计 |
| 方法族≠ | Process / pipeline | Hypothesis test |
| 起源年份≠ | 1990 (model-based adaptive era); rule-based designs from the 1970s–1980s | 1994 |
| 提出者≠ | O'Quigley, Pepe, and Fisher (CRM); earlier rule-based 3+3 designs pre-date it | Bauer & Köhne |
| 类型≠ | Adaptive clinical trial design | Adaptive hypothesis test with interim analyses |
| 开创性文献≠ | O'Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 46(1), 33–48. DOI ↗ | Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗ |
| 别名≠ | adaptive dose-escalation trial, adaptive dose-finding study, model-based adaptive Phase I design | adaptive design, group sequential design, sample size re-estimation, platform trial |
| 相关≠ | 1 | 3 |
| 摘要≠ | An adaptive Phase I clinical trial is a first-in-human or early-phase dose-finding study that continuously updates the recommended dose after each patient cohort using a prespecified statistical model, rather than following a fixed rule. The goal is to identify the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) efficiently while minimising exposure of participants to sub-therapeutic or toxic doses. Adaptive designs — most notably the Continual Reassessment Method (CRM) — replace or augment traditional rule-based designs such as the 3+3 schema. | 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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