N-of-1 Trial
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.
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- 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. · DOI 10.1097/mlr.0b013e318215d90d
- Kravitz, R. L., Duan, N., & Eslick, I. (2010). Evidence-based medicine, heterogeneity of treatment effects, and the trouble with averages. The Milbank Quarterly, 88(4), 503–520. · URL
- Vohra, S., Shamseer, L., Sampson, M., Barrowman, N., Yap, B., Uleryk, E., ... & Moher, D. (2015). CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration. BMJ Open, 5(7), e007838. · DOI 10.1136/bmj.h1793
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