方法对比
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| 贝叶斯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≠ | 1990 | 1960s (formal regulatory framework established ~1963–1970s) |
| 提出者≠ | O'Quigley, Pepe & Fisher (Continual Reassessment Method) | Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines |
| 类型≠ | Adaptive Bayesian dose-finding design | Interventional clinical study design |
| 开创性文献≠ | O'Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 46(1), 33–48. DOI ↗ | Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937. DOI ↗ |
| 别名 | Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study | Phase 1 trial, first-in-human study, FIH study, dose-escalation study |
| 相关≠ | 5 | 6 |
| 摘要≠ | A Bayesian Phase I clinical trial uses prior probability models and sequential Bayes updating to find the maximum tolerated dose (MTD) of a new agent. Unlike the traditional 3+3 rule-based escalation, the Bayesian approach revises a dose-toxicity curve continuously as each patient's outcome is observed, allowing faster convergence to the true MTD while minimising exposure of patients to unsafe or subtherapeutic doses. | 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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