方法对比

	自适应随机临床试验	II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	Late 1990s–2000s (widespread adoption post-2010)	1960s–1970s (formalised in US federal drug regulation)
提出者	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019	U.S. Food and Drug Administration / ICH E8 guidelines (institutionalised framework)
类型	Experimental clinical trial design	Interventional clinical study design
开创性文献	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.	Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185392
别名	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial	Phase 2 trial, Phase II study, early efficacy trial, proof-of-concept trial
相关	6	6
摘要	An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.	A Phase II clinical trial is the second stage in the drug or intervention development pipeline, conducted after Phase I safety testing. Its primary goal is to assess whether the intervention shows preliminary efficacy signals in a relevant patient population at the dose established in Phase I, while continuing to characterise the safety and tolerability profile. Phase II trials are generally smaller than Phase III confirmatory trials and serve as critical go/no-go decision points before large-scale investment.