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Design and analysis of n-of-1 trials


Peter Jüni, MD, FESC, University of Oxford, United Kingdom
Tianjing Li, PhD, University of Colorado Denver, United States of America 
Shaun Treweek, PhD, University of Aberdeen, United Kingdom

This collection is no longer accepting submissions.

Trials invites participant authors to submit to our Collection on Design and analysis of n-of-1 trials. The series of articles will review n-of-1 trials from the literature and will make practical recommendations for implementing the studies including a description of the methods of analysis.

About the Collection

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.

  1. n-of-1 trials are a type of crossover trial designed to optimise the evaluation of health technologies in individual patients. This trial design may be considered for the evaluation of health technologies in r...

    Authors: Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs, Kiera Solaiman, Michael C. H. Quah and Sxe Chang Cheong
    Citation: Trials 2024 25:263

Submission Guidelines

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This Collection welcomes participant authors to submit reviews and original research articles. Before submitting your manuscript, please ensure you have read our submission guidelines. Articles for this Collection should be submitted via our submission system, Editorial Manager. During the submission process you will be asked whether you are submitting to a Collection, please select "Design and analysis of n-of-1 trials" from the dropdown menu.

Articles will undergo the journal’s standard peer-review process and are subject to all of the journal’s standard policies. Articles will be added to the Collection as they are published.

The Editors have no competing interests with the submissions which they handle through the peer-review process. The peer-review of any submissions for which the Editors have competing interests is handled by another Editorial Board Member who has no competing interests.