SPIRIT 2013 statement: defining standard protocol items for clinical trials - PubMed (original) (raw)

Practice Guideline

. 2013 Feb 5;158(3):200-7.

doi: 10.7326/0003-4819-158-3-201302050-00583.

Jennifer M Tetzlaff, Douglas G Altman, Andreas Laupacis, Peter C Gøtzsche, Karmela Krleža-Jerić, Asbjørn Hróbjartsson, Howard Mann, Kay Dickersin, Jesse A Berlin, Caroline J Doré, Wendy R Parulekar, William S M Summerskill, Trish Groves, Kenneth F Schulz, Harold C Sox, Frank W Rockhold, Drummond Rennie, David Moher

Affiliations

Practice Guideline

SPIRIT 2013 statement: defining standard protocol items for clinical trials

An-Wen Chan et al. Ann Intern Med. 2013.

Abstract

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

PubMed Disclaimer

Conflict of interest statement

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1905.

Figures

Figure

Figure

Example template of recommended content for the schedule of enrollment, interventions, and assessments.

Similar articles

Cited by

References

    1. Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA. 2004;292:1359–62. - PubMed
    1. Strengthening the credibility of clinical research [Editorial] Lancet. 2010;375:1225. - PubMed
    1. Summerskill W, Collingridge D, Frankish H. Protocols, probity, and publication. Lancet. 2009;373:992. - PubMed
    1. Jones G, Abbasi K. Trial protocols at the BMJ [Editorial] BMJ. 2004;329:1360. - PMC - PubMed
    1. Groves T. Let SPIRIT take you … towards much clearer trial protocols. [on 1 October 2012];BMJ Group Blogs. 2009 Sep 25; Accessed at http://blogs.bmj.com/bmj/2009/09/25/trish-groves-let-spirit-take-you-tow...

Publication types

MeSH terms

LinkOut - more resources