Butcher, Isabella

Krishan, Ashma

Lewis, Steff

Murray, Gordon

Rodriguez Carbonell, Aryelly

Weir, Christopher

Trials

PubMed

Aryelly Rodriguez

Steff Lewis

Gordon Murray

Ashma Krishan

Isabella Butcher

Christopher Weir

Springer - Publisher Connector

ORAL PRESENTATION Open Access
Statistical analysis plans (SAPS) for academic
clinical trials at the edinburgh clinical trials unit:
what should they contain?
Aryelly Rodriguez2*, Steff Lewis1,2, Gordon Murray1,2, Ashma Krishan2, Isabella Butcher1, Christopher Weir1,3
From 2nd Clinical Trials Methodology Conference: Methodology Matters
Edinburgh, UK. 18-19 November 2013
Once a study protocol is final, the creation of the Statistical
Analysis Plan (SAP) can commence. Accordingly to ICH
E9 a SAP “contains a more technical and detailed elabora-
tion of the principal features of the analysis described in
the protocol” but the level of detail is not specified. This
topic is currently being discussed between UK-CRC regis-
tered Trials Units, and there is as yet no agreement on the
amount of detail that should be covered in the SAP.
Within the Edinburgh Clinical Trials Unit (ECTU), we cre-
ated a consensus document outlining what we thought the
essential aspects of a SAP should be.
Briefly, we set out the essential aspects of a SAP as fol-
lows. It should be written by someone who has not seen
unblinded data from the trial, and should describe analyses
unambiguously and in sufficient detail for another statisti-
cian to be able to repeat them. It should include a brief
description of the trial design, and the statistical methods
section from the protocol. Analysis populations, e.g. ITT,
per protocol, should be defined in an unambiguous fash-
ion. The SAP should state overall level of significance, and
any other relevant information that will be used in the
majority of analyses (e.g. treatment of missing data, adjust-
ment for covariates, adjustment for multiplicity, adjust-
ment of p-value due to interim analyses). A list of analyses
should describe each precise outcome, the analysis method
to be used, any sensitivity analyses, any deviations from
the methods listed in ‘Overall Statistical Principles’, and
any subgroup analyses.
Authors’ details
1Centre for Population Health Sciences-University of Edinburgh, Edinburgh,
UK. 2ECTU-University of Edinburgh, Edinburgh, UK. 3HSRU, Edinburgh, UK.
Published: 29 November 2013
doi:10.1186/1745-6215-14-S1-O102
Cite this article as: Rodriguez et al.: Statistical analysis plans (SAPS) for
academic clinical trials at the edinburgh clinical trials unit: what should
they contain? Trials 2013 14(Suppl 1):O102.
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Submit your manuscript at 
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Full list of author information is available at the end of the article
Rodriguez et al. Trials 2013, 14(Suppl 1):O102
http://www.trialsjournal.com/content/14/S1/O102 TRIALS
© 2013 Rodriguez et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.


Statistical analysis plans (SAPS) for academic clinical trials at the edinburgh clinical trials unit: what should they contain?

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     Edinburgh Research Explorer                                      Statistical analysis plans (SAPS) for academic clinical trials atthe edinburgh clinical trials unit: what should they contain?Citation for published version:Rodriguez Carbonell, A, Lewis, S, Murray, G, Krishan, A, Butcher, I & Weir, C 2013, 'Statistical analysisplans (SAPS) for academic clinical trials at the edinburgh clinical trials unit: what should they contain?'Trials, vol. 14, no. Suppl 1, pp. O102. DOI: 10.1186/1745-6215-14-S1-O102Digital Object Identifier (DOI):10.1186/1745-6215-14-S1-O102Link:Link to publication record in Edinburgh Research ExplorerDocument Version:Publisher's PDF, also known as Version of recordPublished In:TrialsPublisher Rights Statement:© 2013 Rodriguez et al; licensee BioMed Central Ltd.This is an Open Access article distributed under the terms of the Creative Commons Attribution License(http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.General rightsCopyright for the publications made accessible via the Edinburgh Research Explorer is retained by the author(s)and / or other copyright owners and it is a condition of accessing these publications that users recognise andabide by the legal requirements associated with these rights.Take down policyThe University of Edinburgh has made every reasonable effort to ensure that Edinburgh Research Explorercontent complies with UK legislation. If you believe that the public display of this file breaches copyright pleasecontact openaccess@ed.ac.uk providing details, and we will remove access to the work immediately andinvestigate your claim.Download date: 05. Apr. 2019ORAL PRESENTATION Open AccessStatistical analysis plans (SAPS) for academicclinical trials at the edinburgh clinical trials unit:what should they contain?Aryelly Rodriguez2*, Steff Lewis1,2, Gordon Murray1,2, Ashma Krishan2, Isabella Butcher1, Christopher Weir1,3From 2nd Clinical Trials Methodology Conference: Methodology MattersEdinburgh, UK. 18-19 November 2013Once a study protocol is final, the creation of the StatisticalAnalysis Plan (SAP) can commence. Accordingly to ICHE9 a SAP “contains a more technical and detailed elabora-tion of the principal features of the analysis described inthe protocol” but the level of detail is not specified. Thistopic is currently being discussed between UK-CRC regis-tered Trials Units, and there is as yet no agreement on theamount of detail that should be covered in the SAP.Within the Edinburgh Clinical Trials Unit (ECTU), we cre-ated a consensus document outlining what we thought theessential aspects of a SAP should be.Briefly, we set out the essential aspects of a SAP as fol-lows. It should be written by someone who has not seenunblinded data from the trial, and should describe analysesunambiguously and in sufficient detail for another statisti-cian to be able to repeat them. It should include a briefdescription of the trial design, and the statistical methodssection from the protocol. Analysis populations, e.g. ITT,per protocol, should be defined in an unambiguous fash-ion. The SAP should state overall level of significance, andany other relevant information that will be used in themajority of analyses (e.g. treatment of missing data, adjust-ment for covariates, adjustment for multiplicity, adjust-ment of p-value due to interim analyses). A list of analysesshould describe each precise outcome, the analysis methodto be used, any sensitivity analyses, any deviations fromthe methods listed in ‘Overall Statistical Principles’, andany subgroup analyses.Authors’ details1Centre for Population Health Sciences-University of Edinburgh, Edinburgh,UK. 2ECTU-University of Edinburgh, Edinburgh, UK. 3HSRU, Edinburgh, UK.Published: 29 November 2013doi:10.1186/1745-6215-14-S1-O102Cite this article as: Rodriguez et al.: Statistical analysis plans (SAPS) foracademic clinical trials at the edinburgh clinical trials unit: what shouldthey contain? Trials 2013 14(Suppl 1):O102.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submit2ECTU-University of Edinburgh, Edinburgh, UKFull list of author information is available at the end of the articleRodriguez et al. Trials 2013, 14(Suppl 1):O102http://www.trialsjournal.com/content/14/S1/O102 TRIALS© 2013 Rodriguez et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.

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Statistical analysis plans (SAPS) for academic clinical trials at the edinburgh clinical trials unit: what should they contain?

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