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SPIRIT 2025 statement: updated guideline for protocols of randomised trials.
An-Wen Chan1, Isabelle Boutron2, Sally Hopewell3
1Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, ON, Canada.
Lancet (London, England)
|June 15, 2026
Summary
The updated SPIRIT 2025 guidelines enhance randomized trial protocols by adding new items on open science and patient involvement. This aims to improve the completeness and transparency of clinical trial reporting for all stakeholders.
Area of Science:
- Clinical Trials
- Research Methodology
- Scientific Reporting
Background:
- Randomized trial protocols are crucial for study planning, conduct, and reporting, but often lack completeness.
- The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement was established in 2013 to improve protocol completeness.
- Periodic updates are necessary to ensure SPIRIT guidance remains current with evolving evidence and best practices.
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