方法对比

	实用性随机临床试验	自适应随机临床试验
领域	流行病学	流行病学
方法族	Process / pipeline	Process / pipeline
起源年份	1967	Late 1990s–2000s (widespread adoption post-2010)
提出者	Daniel Schwartz & Joseph Lellouch	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
类型	Interventional study design	Experimental clinical trial design
开创性文献	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
别名	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
相关	6	6
摘要	A pragmatic randomized clinical trial (pragmatic RCT) is an interventional study that tests whether a treatment works under routine clinical conditions, as opposed to the tightly controlled setting of an explanatory trial. It prioritizes broad eligibility, flexible delivery, and patient-relevant outcomes to answer the question 'Does this treatment work in everyday practice?' rather than 'Can this treatment work under ideal circumstances?' The distinction between pragmatic and explanatory trials was formally articulated by Schwartz and Lellouch in 1967 and operationalized by the PRECIS tool in 2009.	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.