Interpretation and Examples:Key Updates in SPIRIT 2025 Statement
- VernacularTitle:SPIRIT 2025更新要点实例解读
- Author:
Zelei DAI
1
;
Renjie ZHAO
;
Kefan LI
;
Yonggang ZHANG
;
Nian LI
;
Wenjie YANG
;
Lei LIU
;
Lingmin CHEN
Author Information
- Keywords: SPIRIT 2025; Clinical trial protocol; Reporting guidelines; Interpretation
- From: Journal of Sichuan University (Medical Sciences) 2025;56(3):686-696
- CountryChina
- Language:Chinese
- Abstract: A high-quality clinical trial protocol is the cornerstone for ensuring the scientific integrity and ethical compliance of a study.The Standard Protocol Items:Recommendations for Interventional Trials(SPIRIT)has become the international benchmark for developing clinical trial protocols since its release in 2013.To adapt to the developing trends of open science and patient-centered principles,the SPIRIT group completed a comprehensive update in 2025.While retaining its core structure,this updated guideline introduces a new open science module and incorporates several new elements,including patient and public involvement,trial monitoring,and data sharing,alongside substantial revisions of five pre-existing items.In this article,we critically examine the core revisions in SPIRIT 2025 and,through analysis of representative case studies,illustrate the practical application of the new reporting guideline in drafting trial protocols.Our goal is to to provide Chinese researchers with a valuable reference for understanding and implementing this new reporting guideline,thereby enhancing the quality and rigor of clinical trial protocols developed in the country.
