השוואת שיטות

	ניסוי N-of-1	מחקרים מבוססי ראיות מהעולם האמיתי
תחום	מחקר קליני	מחקר קליני
משפחה	Process / pipeline	Process / pipeline
שנת המקור	1990s-2010s	2010s-present
הוגה השיטה	Kravitz, Duan, Vohra, and single-patient methodology pioneers	FDA, EMA, and health agencies; Sherman et al. (2016) defined RWE formally
סוג	Research Design	Research Design
מקור מכונן	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.	Sherman, R. E., Anderson, S. A., Dal Pan, G. J., Gray, G. W., Gross, T., Hunter, N. L., ... & Califf, R. M. (2016). Real-world evidence—what is it and what can it tell us? New England Journal of Medicine, 375(23), 2293–2297.
כינויים	single-patient RCT, n=1 trial, individual RCT, crossover n-of-1	real-world evidence, RWE, RWD, effectiveness research
קשורות	3	3
תקציר	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.	Real-World Evidence (RWE) is clinical evidence derived from Real-World Data (RWD)—data routinely collected in clinical practice from electronic health records, insurance claims, patient registries, and other healthcare sources. Formalized by the FDA in 2016 (Sherman et al.), RWE addresses a critical gap: while randomized trials test drugs under ideal conditions, RWE evaluates how treatments actually work in diverse, real patients with comorbidities, competing medications, and varied adherence. RWE complements (not replaces) trial evidence, accelerating regulatory decision-making and supporting post-market surveillance.