方法对比
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| 随机对照试验 (RCT)× | 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≠ | 1948 | 1994 |
| 提出者≠ | James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948) | Bauer & Köhne |
| 类型≠ | Interventional comparative study | Adaptive hypothesis test with interim analyses |
| 开创性文献≠ | Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332. DOI ↗ | Bauer, P. & Köhne, K. (1994). Evaluation of Experiments with Adaptive Interim Analyses. Biometrics, 50(4), 1029–1041. DOI ↗ |
| 别名≠ | RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı | adaptive design, group sequential design, sample size re-estimation, platform trial |
| 相关≠ | 7 | 3 |
| 摘要≠ | A randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010). | 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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