手法を比較

	実用的ランダム化比較試験	クラスターランダム化比較試験
分野	実験計画法	実験計画法
系統	Process / pipeline	Process / pipeline
提唱年	1967	1978–1980s
提唱者	Daniel Schwartz and Joseph Lellouch	Cornfield (1978); systematised by Donner and colleagues (1980s)
種類	Experimental design — pragmatic trial	Experimental design
原典	Schwartz, D., & Lellouch, J. (1967). Explanatory and pragmatic attitudes in therapeutical trials. Journal of Chronic Diseases, 20(8), 637–648.	Donner, A., & Klar, N. (2000). Design and Analysis of Cluster Randomization Trials in Health Research. Arnold. ISBN: 978-0340652978
別名	pRCT, pragmatic trial, practical clinical trial, real-world RCT	cluster RCT, group-randomized trial, community randomized trial, cluster-randomized experiment
関連	4	4
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.	A cluster randomized controlled trial (cluster RCT) is an experimental design in which intact social or organisational groups — such as schools, clinics, villages, or workplaces — are randomly assigned to treatment conditions rather than individual participants. Outcomes are still measured at the individual level, but the unit of randomization is the cluster. This design is essential when an intervention is delivered to whole groups, when there is a risk of contamination between participants in the same setting, or when individual randomization is logistically or ethically impractical.