方法对比
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| 回顾性III期临床试验× | 随机对照试验 (RCT)× | |
|---|---|---|
| 领域 | 流行病学 | 流行病学 |
| 方法族 | Process / pipeline | Process / pipeline |
| 起源年份≠ | Late 20th century (ICH E8 1997; widespread retrospective Phase III use from 1990s onward) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| 提出者≠ | Regulatory framework codified by ICH E8/E9 (1997–1998); retrospective application developed through post-marketing and registry practice | Austin Bradford Hill; MRC Streptomycin Trial team |
| 类型≠ | Retrospective comparative clinical study | Interventional experimental study |
| 开创性文献≠ | Friedman, L. M., Furberg, C. D., & DeMets, D. L. (2010). Fundamentals of Clinical Trials (4th ed.). Springer. ISBN: 978-1441915856 | 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 |
| 别名 | retrospective Phase III study, historical Phase III trial, Phase III retrospective analysis, retrospective comparative efficacy trial | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| 相关≠ | 5 | 6 |
| 摘要≠ | A retrospective Phase III clinical trial evaluates the comparative efficacy and safety of an intervention against a control using data that were collected before the study was designed. Rather than enrolling new patients prospectively, researchers analyze existing records — from registries, hospital databases, or historical trial archives — to address a Phase III-level question: does Treatment A outperform the current standard of care in a large, representative patient population? This design is used when prospective enrollment is infeasible, unethical, or when historical data are sufficiently complete to support a rigorous comparison. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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