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Research Methods & Reporting

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.e7586 (Published 09 January 2013) Cite this as: BMJ 2013;346:e7586
  1. An-Wen Chan, Phelan scientist1,
  2. Jennifer M Tetzlaff, research coordinator2,
  3. Peter C Gøtzsche, professor and director3,
  4. Douglas G Altman, professor and director4,
  5. Howard Mann, programme associate5,
  6. Jesse A Berlin, vice president, epidemiology6,
  7. Kay Dickersin, professor and director7,
  8. Asbjørn Hróbjartsson, senior researcher3,
  9. Kenneth F Schulz, distinguished scientist8,
  10. Wendy R Parulekar, associate professor9,
  11. Karmela Krleža-Jerić, adjunct professor10,
  12. Andreas Laupacis, professor11,
  13. David Moher, senior scientist210
  1. 1Women’s College Research Institute at Women’s College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8
  2. 2Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada
  3. 3Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark
  4. 4Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  5. 5Division of Medical Ethics and Humanities, University of Utah School of Medicine, Salt Lake City, USA
  6. 6Janssen Research and Development, Titusville, USA
  7. 7Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA
  8. 8Quantitative Sciences, FHI 360, Research Triangle Park, USA
  9. 9NCIC Clinical Trials Group, Cancer Research Institute, Queen’s University, Kingston, Canada
  10. 10Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  11. 11Keenan Research Centre at the Li Ka Shing Knowledge Institute of St Michael’s Hospital, Faculty of Medicine, University of Toronto, Toronto, Canada
  1. Correspondence to: A-W Chan anwen.chan{at}utoronto.ca
  • Accepted 4 October 2012

Abstract

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol.

This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org).

The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

Footnotes

  • We thank Raymond Daniel for his help with reference management and Jessica Kitchen for her work with manuscript formatting and identification of protocol examples. We also acknowledge GlaxoSmithKline for providing a sample of their trial protocols to serve as potential examples.

  • Contributors: AWC, JT, and DM conceived of the paper. All authors contributed to the drafting and revision of the manuscript, and approve the final version. AWC is the guarantor for the article.

  • Funding: The SPIRIT meetings were funded by the Canadian Institutes of Health Research (CIHR grant DET - 106068); National Cancer Institute of Canada (now Canadian Cancer Society Research Institute); and Canadian Agency for Drugs and Technologies in Health. CIHR has also funded ongoing dissemination activities (grant MET-117434). KKJ was formerly employed by CIHR (Knowledge Translation Branch), and WRP is affiliated with the NCIC Clinical Trials Group. The funders had no input into the design and conduct of the project; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

  • Competing interests: All authors have completed the ICJME unified declaration form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: JAB is employed by the Janssen Pharmaceutical Companies of Johnson & Johnson; KKJ was formerly employed by CIHR (Knowledge Translation Branch), and WRP is affiliated with the NCIC Clinical Trials Group. Trish Groves is deputy editor of BMJ and a member of the SPIRIT group but did not take part in the peer review and decision making process about this publication.

  • Provenance and peer review: Not commissioned; externally peer reviewed.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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