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Open Access 01-12-2020 | Editorial

Prospective reporting of statistical analysis plans for randomised controlled trials

Authors: Karla Hemming, Anna Kearney, Carrol Gamble, Tianjing Li, Peter Jüni, An-Wen Chan, Matthew R. Sydes

Published in: Trials | Issue 1/2020

Excerpt

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]. …

Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–43. https://doi.org/10.1001/jama.2017.18556 PubMed PMID: 29260229..CrossRefPubMed

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMedPubMedCentral

Spence O, Hong K, Onwuchekwa Uba R, Doshi P. Availability of study protocols for randomized trials published in high-impact medical journals: a cross-sectional analysis. Clin Trials. 2020;17(1):99–105. https://doi.org/10.1177/1740774519868310.CrossRefPubMed

[ICH E9 1998] International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline: statistical principles for clinical trials E9. London, England: European Medicines Agency; 1998.

Dwan K, Altman DG, Clarke M, Gamble C, Higgins JP, Sterne JA, Williamson PR, Kirkham JJ. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials. PLoS Med. 2014;11(6):e1001666.CrossRefPubMedPubMedCentral

Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, Williamson PR. The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ. 2010;340:c365.CrossRefPubMed

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. Consolidated Standards of Reporting Trials Group. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63(8):e1–37.CrossRefPubMed

[Trials submission site] (https://trialsjournal.biomedcentral.com/submission-guidelines/preparing-your-manuscript/update). Accessed 26 Oct 2020.

[ICJME site] http://www.icmje.org/recommendations/browse/roles-and-responsibilities/responsibilities-in-the-submission-and-peer-peview-process.html. Accessed 26 Oct 2020.

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Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32 PMID: 20334632.CrossRefPubMedPubMedCentral

Title: Prospective reporting of statistical analysis plans for randomised controlled trials
Authors: Karla Hemming
Anna Kearney
Carrol Gamble
Tianjing Li
Peter Jüni
An-Wen Chan
Matthew R. Sydes
Publication date: 01-12-2020
Publisher: BioMed Central
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04828-8

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Prospective reporting of statistical analysis plans for randomised controlled trials

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