Prospective reporting of statistical analysis plans for randomised controlled trials
Open accessAbstract
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].
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Typically, the statistical analysis plan is a separate document that should be read in conjunction with the protocol, but for some trials with simple analyses, it can be included as part of the protocol.
“Typically, the statistical analysis plan is a separate document that should be read in conjunction with the protocol, but for some trials with simple analyses, it can be included as part of the protocol.72”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [72]
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Cites
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · BMC Medicine · doi:10.1186/1741-7015-8-18 · Cited by 13,371 · see citing works
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883 · see citing works
SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
Chan, A.-W., Tetzlaff, J. M., Altman, D. G., Laupacis, A., Gøtzsche, P. C., Krleža-Jerić, K., Hróbjartsson, A., Mann, H., Dickersin, K., Berlin, J. A., et al. (2013) · Annals of Internal Medicine · doi:10.7326/0003-4819-158-3-201302050-00583 · Cited by 7,363 · see citing works
Self-citationCONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
the CONSORT Group, Schulz, K. F., Altman, D. G., & Moher, D. (2010) · Trials · doi:10.1186/1745-6215-11-32 · Cited by 1,871 · see citing works
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2010.03.004 · Cited by 1,858 · see citing works
Kirkham, J. J., Dwan, K. M., Altman, D. G., Gamble, C., Dodd, S., Smyth, R., & Williamson, P. R. (2010) · BMJ · doi:10.1136/bmj.c365 · Cited by 1,133 · see citing works
Self-citationGuidelines for the Content of Statistical Analysis Plans in Clinical Trials
Gamble, C., Krishan, A., Stocken, D., Lewis, S., Juszczak, E., Doré, C., Williamson, P. R., Altman, D. G., Montgomery, A., Lim, P., et al. (2017) · JAMA · doi:10.1001/jama.2017.18556 · Cited by 536 · see citing works
Self-citationMoher, D., Hopewell, S., Schulz, K. F., Montori, V. M., Gøtzsche, P. C., Devereaux, P. J., Elbourne, D. R., Egger, M., & Altman, D. G. (2011) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2011.10.006 · Cited by 414 · see citing works
Dwan, K., Altman, D. G., Clarke, M., Gamble, C., Higgins, J. P. T., Sterne, J. A. C., Williamson, P. R., & Kirkham, J. J. (2014) · PLoS Medicine · doi:10.1371/journal.pmed.1001666 · Cited by 187 · see citing works
Self-citationSpence, O., Hong, K., Onwuchekwa Uba, R., & Doshi, P. (2020) · Clinical Trials · doi:10.1177/1740774519868310 · Cited by 37 · see citing works
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Research works printed but not linked: 2
- [4][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. 1998 London, England European Medicines Agency
- [8][Trials submission site] (https://trialsjournal.biomedcentral.com/submission-guidelines/preparing-your-manuscript/update). Accessed 26 Oct 2020.
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SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials
Hróbjartsson, A., Boutron, I., Hopewell, S., Moher, D., Schulz, K. F., Collins, G. S., Tunn, R., Aggarwal, R., Berkwits, M., Berlin, J. A., et al. (2025) · BMJ · doi:10.1136/bmj-2024-081660 · Cited by 171 · see citing works
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- Authors
- Hemming, K., Kearney, A., Gamble, C., Li, T., Jüni, P., Chan, A.-W., & Sydes, M. R.
- Affiliations
- University of Birmingham (GB)
- University of Liverpool (GB)
- University of Colorado Anschutz (US)
- St. Michael's Hospital (CA)
- University of Toronto (CA)
- MRC Clinical Trials Unit at UCL (GB)
- Corresponding author
- Hemming, Karla
- Venue
- Trials
- Published
- 2020-10-28
- Volume
- 21
- Issue
- 1
- Pages
- 898-898
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC7594284
- OpenAlex
- W3095928632
- Cited by
- 34
- References
- 10
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 13 · 2023: 6 · 2022: 4 · 2021: 3
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- TSpace (University of Toronto) (submittedVersion, cc-by)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- National Institute for Health and Care Research (SRF-2017-10-002)
- Medical Research Council (MC_UU_12023/24)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- statistical analysis plan, randomized controlled trials, EQUATOR Network, statistical analysis reporting
- MeSH terms
- Humans, Prospective Studies, Research Design
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