方法对比

	试点随机对照试验	整群随机对照试验
领域	实验设计	实验设计
方法族	Process / pipeline	Process / pipeline
起源年份	1990s–2000s (methodological formalization)	1978–1980s
提出者	Formalized through clinical trials methodology community	Cornfield (1978); systematised by Donner and colleagues (1980s)
类型	Experimental feasibility design	Experimental design
开创性文献	Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., ... & Goldsmith, C. H. (2010). A tutorial on pilot studies: the what, why and how. BMC Medical Research Methodology, 10(1), 1.	Donner, A., & Klar, N. (2000). Design and Analysis of Cluster Randomization Trials in Health Research. Arnold. ISBN: 978-0340652978
别名	pilot RCT, feasibility RCT, pilot trial, preliminary RCT	cluster RCT, group-randomized trial, community randomized trial, cluster-randomized experiment
相关	5	4
摘要	A pilot randomized controlled trial (pilot RCT) is a small-scale, fully randomized experiment conducted before a definitive RCT to test the feasibility of study procedures, estimate key parameters such as recruitment rates and effect-size variability, and identify practical barriers. It uses the same randomization, intervention, and measurement protocol as the planned full trial but on a fraction of the target sample. The goal is not to confirm efficacy but to refine and justify the main trial design.	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.