方法对比

	风险调整的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	1990s–2000s	1960s (formal regulatory framework established ~1963–1970s)
提出者	Evolved from the Continual Reassessment Method (O'Quigley et al., 1990) extended with patient-level risk covariates	Regulatory and clinical pharmacology community; formalized in U.S. FDA IND regulations (1963) and ICH guidelines
类型	Interventional clinical trial design	Interventional clinical study design
开创性文献	Iasonos, A., Wilton, A. S., & Gonen, M. (2008). A review of stochastic dose-finding methods. Statistics in Medicine, 27(25), 5031–5046.	Storer, B. E. (1989). Design and analysis of phase I clinical trials. Biometrics, 45(3), 925–937.
别名	risk-stratified Phase I trial, risk-adaptive dose-escalation study, covariate-adjusted Phase I study, risk-based dose-finding trial	Phase 1 trial, first-in-human study, FIH study, dose-escalation study
相关	5	6
摘要	A risk-adjusted Phase I clinical trial is a first-in-human or dose-finding study that explicitly incorporates patient-level risk covariates — such as organ function, prior therapy, or genetic markers — into the dose-escalation model. Rather than treating all enrolled participants as homogeneous, the design accounts for individual differences in tolerance, allowing the recommended dose to vary by risk stratum. This approach is especially common in oncology, where patients with impaired renal function or heavily pre-treated disease may tolerate lower doses than the broader population.	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.