Guidance for designing n-of-1 trials (the DIAMOND project)

n-of-1 trials are multi-period crossover trials designed to evaluate health technologies within individual patients. The DIAMOND project (Development of a generalisable methodology for n-of-1 trials delivery for very low volume treatments) was undertaken to facilitate the application of n-of-1 trials, particularly in rare disease research, by producing guidance on the design, implementation, and analysis of n-of-1 trials.

The project was reviewed by the University of Sheffield’s School of Health and Related Research’s independent Ethics Committee (application number 039799).