SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

An‐Wen Chan(Women's College Hospital), Jennifer Tetzlaff(University of Ottawa), Douglas G. Altman(Women's College Hospital), Andreas Laupacis(Centre of Biomedical Research), Peter C Gøtzsche(Women's College Hospital), Karmela Krleža-Jerić(University of Ottawa), Asbjørn Hróbjartsson(University of Copenhagen), Howard Mann(Johns Hopkins University), Kay Dickersin(Women's College Hospital), Jesse A. Berlin(Janssen (Belgium)), Caroline J Doré(Medical Research Council), Wendy R. Parulekar(Johns Hopkins University), William Summerskill(Women's College Hospital), Trish Groves(British Medical Association), Kenneth F. Schulz(Johns Hopkins University), Harold C. Sox(Dartmouth College), Frank W. Rockhold(Women's College Hospital), Drummond Rennie(University of California, San Francisco), David Moher(Johns Hopkins University)
Annals of Internal Medicine
February 5, 2013
10.7326/0003-4819-158-3-201302050-00583
Cited by 7,943Open Access
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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.

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