The n-of-1 clinical trial: the ultimate strategy for individualizing medicine?

Author:

Lillie Elizabeth O12,Patay Bradley12,Diamant Joel12,Issell Brian12,Topol Eric J1234,Schork Nicholas J

Affiliation:

1. Scripps Health, La Jolla, CA 92037, USA

2. The Scripps Translational Science Institute, La Jolla, CA 92037, USA

3. The Scripps Research Institute, La Jolla, CA 92047, USA

4. The West Wireless Health Institute, La Jolla, CA 92037, USA

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.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Molecular Medicine,General Medicine

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