方法对比

	试点随机对照试验	自适应随机对照试验
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)	1980s–2000s (formalized; earlier sequential testing roots from Wald, 1947)
提出者	Formalized through clinical trials methodology community	Donald Berry and others; foundational adaptive trial methods developed through 1980s–2000s biostatistics literature
类型	Experimental feasibility design	Experimental design — adaptive variant of RCT
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.	Chow, S.-C., & Chang, M. (2008). Adaptive Design Methods in Clinical Trials. Chapman & Hall/CRC. ISBN: 978-1584887690
别名	pilot RCT, feasibility RCT, pilot trial, preliminary RCT	Adaptive RCT, Response-adaptive RCT, Adaptive clinical trial, Platform trial
相关	5	6
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.	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.