方法对比
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| 匹配的II期临床试验× | II期临床试验× | |
|---|---|---|
| 领域 | 流行病学 | 流行病学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | 1960s–1980s (formalized with Simon optimal designs, 1989) | 1960s–1970s (formalised in US federal drug regulation) |
| 提出者≠ | Gehan (1961) for Phase II designs; matching frameworks adapted from case-control methodology | U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework) |
| 类型≠ | Controlled clinical trial design | Interventional clinical study design |
| 开创性文献≠ | Gehan, E. A. (1961). The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. Journal of Chronic Diseases, 13(4), 346–353. DOI ↗ | 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 |
| 别名 | matched Phase II trial, historically matched Phase II study, propensity-matched Phase II trial, externally controlled Phase II trial | Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial |
| 相关≠ | 5 | 6 |
| 摘要≠ | A matched Phase II clinical trial is a single-arm or small-controlled early-efficacy study in which treated patients are paired with matched controls — drawn from historical databases, registries, or concurrent external cohorts — on key prognostic variables such as age, disease stage, and performance status. This design allows preliminary efficacy assessment without a concurrent randomized arm, trading randomization for feasibility while partially controlling for confounding through the matching process. | 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. |
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