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SPIRIT 2013 statement: defining standard protocol items for clinical trials.
An-Wen Chan1, Jennifer M Tetzlaff, Douglas G Altman
1Women’s College Research Institute, Women’s College Hospital, University of Toronto, 790 Bay Street, Toronto, Ontario M5G 1N8, Canada. anwen.chan@utoronto.ca
Annals of Internal Medicine
|January 9, 2013
Summary
The SPIRIT 2013 checklist provides essential guidelines for clinical trial protocols, ensuring comprehensive content for better study planning and reporting. Adherence enhances transparency and quality for all stakeholders involved in clinical research.
Area of Science:
- Clinical Trial Methodology
- Research Protocol Development
- Evidence-Based Medicine
Background:
- Clinical trial protocols are crucial for study planning, conduct, and reporting.
- Existing protocol guidelines exhibit significant variability in content and quality.
- A need exists for standardized recommendations to improve protocol development.
Framework:
- SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 is a guideline for minimum clinical trial protocol content.
- The SPIRIT checklist comprises 33 items applicable to all interventional trial protocols.
- It focuses on essential content rather than prescriptive formatting or trial design.
Implementation:
- The SPIRIT checklist guides the comprehensive description of planned trial elements.
- It aims to facilitate the drafting of high-quality clinical trial protocols.
- SPIRIT recommendations do not dictate trial design or conduct methods.
Implications:
- Adherence to SPIRIT enhances protocol transparency and completeness.
- Improved protocols benefit investigators, participants, patients, and sponsors.
- SPIRIT supports ethical review, peer review, publication, and regulatory processes.
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