Prospective reporting of statistical analysis plans for randomised controlled trials
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EDITORIAL
Open Access
Prospective reporting of statistical analysis plans for randomised controlled trials Karla Hemming1*, Anna Kearney2, Carrol Gamble2, Tianjing Li3, Peter Jüni4, An-Wen Chan5 and Matthew R. Sydes6 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 [2–4]. Given the influence of statistical decisions on trial conclusions, well-documented statistical conduct is essential for transparency and reproducibility of the research. Additionally, pre-specification is important to reduce the occurrence of, and facilitate the detection of, bias particularly in relation to selective analysis and reporting [5, 6]. While guidance exists on the content of protocols [2] and final reports for clinical trials [7], both of which require at a minimum a summary of the statistical analyses, there was until recently no guidance on SAP content. Consequently, there is marked variation in the level of detail provided to allow full replication of statistical analysis. The development of guidance for the content of SAPs aims to reduce this variation and to promote full and transparent reporting of pre-specified analyses [1]. Trials therefore encourages the submission for publication of SAPs, which are in line with the guidance document [1], in any of the following formats: (i) A section directly integrated in the protocol being submitted for publication (for uncomplicated RCTs this might be sufficient); * Correspondence: [email protected] 1 Institute of Applied Health Research, University of Birmingham, Birmingham, UK Full list of author information is available at the end of the article
(ii) An appendix within the protocol being submitted for publication; (iii)An addendum submitted subsequent to the published protocol paper in Trials as a newly peer-reviewed update and which subsequent to publication would be treated much like an appendix to the protocol; (iv) A separate stand-alone, fully published article, with its own author list and DOI, referencing an alreadypublished protocol (in Trials or elsewhere). These options underscore the importance of the publication of SAPs but also ensure that the reporting of SAPs as separate publications is not made mandatory. For many RCTs, the statistical analysis plan is likely to be uncomplicated and feasibly be defined in full at the time of writing the protocol. For more complex trials, such as those with adaptive designs or those using new methodologies, the development of the SAP might take longer than that of the protocol. Trials is actively encouraging researchers to publish their SAPs in the format that fits the complexi
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