方法对比
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| II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≠ | 1960s–1970s (formalised in US federal drug regulation) | Late 1990s–2000s (widespread adoption post-2010) |
| 提出者≠ | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) | Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019 |
| 类型≠ | Interventional clinical 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: 978-3319185392 | Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗ |
| 别名 | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial | adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial |
| 相关 | 6 | 6 |
| 摘要≠ | A Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment. | 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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