Trials invites participant authors to submit to our Collection on Design and analysis of n-of-1 trials.
Trials are required for the evaluation of new health technologies. For trials in rare diseases, the availability of patients may limit the size of the studies. This can impact the evaluation of new health technologies as well as access to them.
n-of-1 trials are multi-period crossover trials designed to evaluate health technologies within individual patients. They may be well placed to evaluate health technologies for rare diseases, however further research into their design and use is required.
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 by producing guidance on the design, implementation, and analysis of n-of-1 trials.
The collection from DIAMOND includes three articles. The first article presents a review of n-of-1 trials undertaken over a ten-year period describing characteristics of the trials, including the number of periods and the types of health technology evaluated. The second article presents a tutorial explaining how a series of n-of-1 trials can be presented and analysed. The third article provides a list of key points to consider in the design, implementation, and analysis of n-of-1 trials.