手法を比較

	実用的ランダム化比較試験	適応的無作為化比較試験
分野	実験計画法	実験計画法
系統	Process / pipeline	Process / pipeline
提唱年	1967	1980s–2000s (formalized; earlier sequential testing roots from Wald, 1947)
提唱者	Daniel Schwartz and Joseph Lellouch	Donald Berry and others; foundational adaptive trial methods developed through 1980s–2000s biostatistics literature
種類	Experimental design — pragmatic trial	Experimental design — adaptive variant of RCT
原典	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.	Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. ISBN: 978-1584887690
別名	pRCT, pragmatic trial, practical clinical trial, real-world RCT	Adaptive RCT, Response-adaptive RCT, Adaptive clinical trial, Platform trial
関連	4	6
概要	A pragmatic randomized controlled trial (pRCT) tests whether an intervention works under ordinary, real-world conditions — broad eligibility, flexible delivery, and routine care settings. Participants are still randomly assigned to treatment or control, preserving causal inference, but the study is designed to reflect the diversity and variability of actual practice rather than the ideal conditions of an explanatory trial. The defining framework is the PRECIS-2 tool, which maps any RCT along nine pragmatic-to-explanatory dimensions.	An adaptive randomized controlled trial (adaptive RCT) is an experimental design in which pre-specified rules allow modifications to the trial while it is ongoing — such as changing allocation ratios, dropping underperforming arms, or stopping early for efficacy or futility — based on accumulating interim data. These adaptations are planned before the trial starts and governed by statistical rules to preserve Type I error control and validity.