方法对比
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| 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≠ | 1962 (Kefauver-Harris Amendment formalised phased drug development) | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| 提出者≠ | FDA regulatory framework / ICH guidelines | Austin Bradford Hill; MRC Streptomycin Trial team |
| 类型≠ | Confirmatory randomised controlled trial | Interventional experimental study |
| 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 | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| 相关 | 6 | 6 |
| 摘要≠ | 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. | 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. |
| ScholarGate数据集 ↗ |
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