手法を比較

	適応的無作為化比較試験	実用的ランダム化比較試験 ― 実臨床における有効性
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	Late 1990s–2000s (widespread adoption post-2010)	1967
提唱者	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019	Daniel Schwartz & Joseph Lellouch
種類	Experimental clinical trial design	Interventional study design
原典	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.
別名	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial	pragmatic RCT, effectiveness trial, real-world RCT, practical clinical trial
関連	6	6
概要	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 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.