手法を比較

	N-of-1試験	ランダム化比較試験 (RCT)
分野	臨床研究	実験計画法
系統	Process / pipeline	Hypothesis test
提唱年	1990s-2010s	1948
提唱者	Kravitz, Duan, Vohra, and single-patient methodology pioneers	James Lind (early precursor, 1747); modern formulation: Austin Bradford Hill & Medical Research Council (1948)
種類	Research Design	Interventional comparative study
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.	Schulz, K.F., Altman, D.G., Moher, D., for the CONSORT Group (2010). CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332.
別名	single-patient RCT, n=1 trial, individual RCT, crossover n-of-1	RCT, randomised controlled trial, clinical trial, Randomize Kontrollü Çalışma (RCT) Tasarımı
関連	3	7
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 randomized controlled trial (RCT) is the gold standard experimental design in clinical and health research, in which participants are randomly allocated to a treatment group or a control group so that the effect of an intervention can be measured with the highest possible degree of internal validity. The modern parallel-group RCT was formalized by Austin Bradford Hill and the Medical Research Council in their landmark streptomycin trial of 1948, and its reporting is governed today by the CONSORT 2010 guidelines (Schulz et al., 2010).