Introducing Data Sciences to N-of-1 Designs, Statistics, Use-Cases, the Future, and the Moniker ‘N-of-1’ Trial

Abstract

This article, an introduction to HDSR’s “Personalized (N-of-1) Trials: Methods, Applications, and Impact” special issue, describes the rationale for a primer of the methods, data types and management, designs, and use cases for personalized (N-of-1) trials. It explains that the design and implementation of personalized (N-of-1) trials is only useful if patients volunteer for research involving them and actively participate in clinical services that use them. However, ‘N-of-1 trials’ may be an inadequate name to enact such patient engagement. The authors briefly review what patients have reported about the ‘N-of-1’ label and propose a more consumer-friendly moniker for this type of research and clinical approach to improve evidence-based science.