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Prospective reporting of statistical analysis plans for randomised controlled trials

Hemming, K; Kearney, A; Gamble, C; Li, T; Jüni, P; Chan, A-W; Sydes, MR; (2020) Prospective reporting of statistical analysis plans for randomised controlled trials. Trials , 21 (1) , Article 898. 10.1186/s13063-020-04828-8. Green open access

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Abstract

In 2017, JAMA published a statistical analysis plan (SAP) guidance document for randomised clinical trials (RCTs). This guidance is part of the EQUATOR Network of reporting resources and includes a checklist of minimum items for reporting details of statistical analysis of RCTs [1]. While the clinical trial protocol should describe the principal features of the statistical analysis, a separate detailed SAP containing sufficient information to support replication by an independent statistician may be needed [2,3,4].

Type: Article
Title: Prospective reporting of statistical analysis plans for randomised controlled trials
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-020-04828-8
Publisher version: https://doi.org/10.1186/s13063-020-04828-8
Language: English
Additional information: © 2020 BioMed Central Ltd. This article is licensed under a Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/).
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 > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10113537
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