方法对比
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| 多中心III期临床试验× | 自适应随机临床试验× | |
|---|---|---|
| 领域 | 流行病学 | 流行病学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1940s–1990s (formalized through ICH harmonization ~1990s) | Late 1990s–2000s (widespread adoption post-2010) |
| 提出者≠ | Codified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| 类型≠ | Confirmatory interventional study design | Experimental clinical trial design |
| 开创性文献≠ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| 别名 | Phase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trial | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| 相关 | 6 | 6 |
| 摘要≠ | A multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites. | An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study. |
| ScholarGate数据集 ↗ |
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