手法を比較

	N-of-1試験	実践的臨床試験
分野	臨床研究	臨床研究
系統	Process / pipeline	Process / pipeline
提唱年	1990s-2010s	2009-2015
提唱者	Kravitz, Duan, Vohra, and single-patient methodology pioneers	Thorpe et al. (2009); PRECIS framework developed by international consortia
種類	Research Design	Research Design
原典	Gabler, N. B., Duan, N., Vohra, S., & Kravitz, R. L. (2011). N-of-1 trials in the medical literature: a systematic review. Medical Care, 49(8), 761–768.	Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Tugwell, P. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 180(10), E47–E57.
別名	single-patient RCT, n=1 trial, individual RCT, crossover n-of-1	pragmatic trial, real-world trial, effectiveness trial, PRECIS-2
関連	3	4
概要	An N-of-1 trial is a single-patient randomized controlled trial in which a patient alternates between treatment A and treatment B (or active drug and placebo) in repeated, randomized cross-over periods. Developed systematically in the 1990s–2010s by Kravitz, Duan, and Vohra, N-of-1 trials enable personalized medicine by determining which treatment works best for that specific individual, avoiding the assumption that population-average effects apply to all patients. They are ideal for chronic conditions with variable outcomes and heterogeneous treatment response.	A pragmatic trial is designed to evaluate the real-world effectiveness of an intervention in typical clinical settings with diverse, representative patients, minimal exclusion criteria, and clinically relevant outcomes. Developed by Thorpe and colleagues (2009) and formalized via the PRECIS-2 framework (2015), pragmatic trials bridge the gap between explanatory efficacy trials (conducted in controlled research settings) and implementation science, answering the question 'Does this work in actual clinical practice?' rather than 'Can this work under ideal conditions?'