The statistical analysis for cluster randomised trials has many complexities not yet addressed by the available guidance for statistical analysis plans. A group from the Institute of Applied Health Research University of Birmingham, Queen Mary University of London, University College London, and Ottawa Hospital Research Institute started developing an extension for the Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. One member of the team of the original guideline will join the group.
A systematic review of the literature and a Delphi survey are planned, as well as a consensus meeting and piloting before publication. The group obtained partial funding from the UK NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands initiative and the MRC-NIHR Develop Guidance for Better Research Methods grant for Developing guidance. They plan to publish the guidance as an open access document in 2024.
Registered: 1 June 2023
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Contact: Karla Hemming Email: [email protected]