N of 1 trial

An N of 1 trial (N=1) is a multiple crossover clinical trial, conducted in a single patient.[1] A trial in which random allocation is used to determine the order in which an experimental and a control intervention are given to a single patient is an N of 1 randomized controlled trial. Some N of 1 trials involve randomized assignment and blinding, but the order of experimental and control interventions can also be fixed by the researcher.[2]

This type of study has enabled practitioners to achieve experimental progress without the work of designing a group comparison study. This design, especially if including blinding and wash-out periods, can be effective in confirming causality. N-of-1 trials, if used in clinical practice to inform therapeutic decisions concerned with the patient participating in the trial, can be a source of evidence about individual treatment responses, fulfilling the promise of personalized medicine.[3][4]

  1. ^ "Introduction to N-of-1 Trials: Indications and Barriers (Chapter 1) | Effective Health Care (EHC) Program". effectivehealthcare.ahrq.gov. Retrieved 2023-12-31.
  2. ^ Punja, Salima; Bukutu, Cecilia; Shamseer, Larissa; Sampson, Margaret; Hartling, Lisa; Urichuk, Liana; Vohra, Sunita (August 2016). "N-of-1 trials are a tapestry of heterogeneity". Journal of Clinical Epidemiology. 76: 47–56. doi:10.1016/j.jclinepi.2016.03.023. ISSN 1878-5921. PMID 27079847.
  3. ^ Serpico, Davide; Maziarz, Mariusz (2023-12-14). "Averaged versus individualized: pragmatic N-of-1 design as a method to investigate individual treatment response". European Journal for Philosophy of Science. 13 (4): 59. doi:10.1007/s13194-023-00559-0. ISSN 1879-4920.
  4. ^ Nikles, J., & Mitchell, G. (2015). Nikles, Jane; Mitchell, Geoffrey (eds.). "The Essential Guide to N-of-1 Trials in Health" (PDF). SpringerLink. doi:10.1007/978-94-017-7200-6. ISBN 978-94-017-7199-3. S2CID 33597874.{{cite journal}}: CS1 maint: multiple names: authors list (link)