方法对比
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| I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≠ | 1960s (formal regulatory framework established ~1963–1970s) | 1962 (Kefauver-Harris Amendment formalised phased drug development) |
| 提出者≠ | Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines | FDA regulatory framework / ICH guidelines |
| 类型≠ | Interventional clinical study design | Confirmatory randomised controlled trial |
| 开创性文献≠ | Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. 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: 978-3319185385 |
| 别名 | Phase 1 trial, first-in-human study, FIH study, dose-escalation study | Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT |
| 相关 | 6 | 6 |
| 摘要≠ | A Phase I clinical trial is the first stage of human testing for a new drug, biologic, or intervention. Its primary objective is to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) rather than therapeutic efficacy. Small cohorts of participants — typically healthy volunteers or patients with advanced disease — receive sequentially increasing doses to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) that define the boundary for subsequent trials. | 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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