方法对比
并排查看您选择的方法；存在差异的行会高亮显示。
| 随机对照试验 (RCT)× | III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≠ | 1948 (first rigorously conducted RCT — MRC streptomycin trial) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| 提出者≠ | Austin Bradford Hill; MRC Streptomycin Trial team | FDA regulatory framework / ICH guidelines |
| 类型≠ | Interventional experimental study | Confirmatory randomised controlled trial |
| 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 | 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 | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| 相关 | 6 | 6 |
| 摘要≠ | 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. | A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption. |
| ScholarGate数据集 ↗ |
|
|