方法对比
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| 回顾性III期临床试验× | 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≠ | Late 20th century (ICH E8 1997; widespread retrospective Phase III use from 1990s onward) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| 提出者≠ | Regulatory framework codified by ICH E8/E9 (1997–1998); retrospective application developed through post-marketing and registry practice | FDA regulatory framework / ICH guidelines |
| 类型≠ | Retrospective comparative clinical study | Confirmatory randomised controlled trial |
| 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 | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| 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 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. |
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