SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

TLDR

Clinical trial protocols underpin study planning, conduct, reporting, and appraisal, yet existing guidelines vary widely in content and quality. This article outlines the systematic development of SPIRIT 2013, a 33‑item guideline for minimum content of clinical trial protocols, aiming to facilitate the drafting of high‑quality protocols. SPIRIT provides a checklist that specifies required content for all clinical trial protocols, recommending a full description of planned elements without prescribing design or conduct. Adherence to SPIRIT enhances transparency and completeness of trial protocols, benefiting investigators, participants, sponsors, ethics committees, reviewers, journals, registries, policymakers, regulators, and other stakeholders.

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.