title: The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?
abstract: N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine.
authors.affiliation: Scripps Health, La Jolla, CA 92037, USA.
authors.forename: Elizabeth O
authors.initials: EO
authors.lastname: Lillie
authors.forename: Bradley
authors.initials: B
authors.lastname: Patay
authors.forename: Joel
authors.initials: J
authors.lastname: Diamant
authors.forename: Brian
authors.initials: B
authors.lastname: Issell
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Topol
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Schork