方法对比

	多中心I期临床试验	多中心随机临床试验
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)	1970s–1980s (widespread adoption for large-scale efficacy trials)
提出者	Established through FDA regulatory guidance and ICH harmonization frameworks	Evolved from single-center RCT methodology; consolidated through landmark trials such as the MRC streptomycin trial (1948) and large cardiovascular mega-trials of the 1970s–1980s
类型	Interventional clinical study design	Interventional experimental 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.	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	multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial	multi-site RCT, multicenter RCT, multinational randomized trial, multicenter controlled trial
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 multicenter randomized clinical trial (RCT) is an experimental study in which eligible participants are randomly assigned to intervention or control arms simultaneously across two or more clinical sites. By combining the rigor of randomization with enrollment from geographically or institutionally diverse centers, this design produces large samples and externally valid effect estimates that single-center trials rarely achieve. It is the regulatory gold standard for confirmatory efficacy and safety evaluation of new treatments.