Hemming, Karla;
Thompson, Jacqueline Y;
Hooper, Richard L;
Ukoumunne, Obioha C;
Li, Fan;
Caille, Agnes;
Kahan, Brennan C;
... Taljaard, Monica; + view all
(2025)
Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials.
Trials
, 26
(1)
, Article 72. 10.1186/s13063-025-08756-3.
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Abstract
Background Guidance exists to inform the content of statistical analysis plans in clinical trials. Though not explicitly stated, this guidance is generally focused on clinical trials in which the randomization units are individual patients and not groups of patients. There are critical considerations for the analysis of cluster randomized trials, such as accounting for clustering, the risk of imbalances between the arms due to post-randomization recruitment, and the need to use small sample corrections when the number of clusters is small. Methods This paper outlines the protocol for the development of a set of reporting guidelines for the content of statistical analysis plans for cluster randomized trials (including variations such as the stepped wedge cluster randomized trial and other cluster cross-over designs) by extending the minimum reporting analysis requirements as previously defined for individually randomized trials to cluster randomized trials. The guideline will be developed using a consensus-based approach, modifying existing reporting items from the guideline for individually randomized trials and extending to include new items. Discussion The guideline will be developed so it can be used independently of the guideline for individually randomized designs. The consensus guidelines will be published in an open-access journal, including key guidance as well as exploration and elaboration.
| Type: | Article |
|---|---|
| Title: | Guidelines for the content of statistical analysis plans in clinical trials: protocol for an extension to cluster randomized trials |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s13063-025-08756-3 |
| Publisher version: | https://doi.org/10.1186/s13063-025-08756-3 |
| Language: | English |
| Additional information: | Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
| Keywords: | Cluster randomized trials, Group randomization, Statistical analysis plans, Analysis plans, Guidelines |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10205410 |
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