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。
| 多中心I期临床试验× | I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≠ | 1970s–1980s (formalized in FDA Phase I guidance 1977; ICH E6 GCP 1996) | 1960s (formal regulatory framework established ~1963–1970s) |
| 提出者≠ | Established through FDA regulatory guidance and ICH harmonization frameworks | Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines |
| 类型 | Interventional clinical study design | Interventional clinical study design |
| 开创性文献≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). ICH. link ↗ | Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. DOI ↗ |
| 别名 | multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial | Phase 1 trial, first-in-human study, FIH study, dose-escalation study |
| 相关 | 6 | 6 |
| 摘要≠ | A multicenter Phase I clinical trial is the first systematic administration of an investigational agent to humans, conducted simultaneously across two or more clinical sites. Its primary objectives are to characterize the safety and tolerability profile of the intervention, determine the maximum tolerated dose (MTD), and describe pharmacokinetic and pharmacodynamic behavior. Distributing enrollment across sites increases participant accrual speed and enhances the generalizability of early-phase safety data. | 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. |
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