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SPIRIT 2025更新要点实例解读

Interpretation and Examples: Key Updates in SPIRIT 2025 Statement

  • 摘要: 高质量的临床试验方案是确保研究科学性和伦理合规性的基石。临床试验方案报告指南(Standard Protocol Items: Recommendations for Interventional Trials, SPIRIT)自2013年发布以来,已成为临床试验方案撰写的国际共识标准。为适应开放科学趋势和患者中心理念的发展,SPIRIT工作组于 2025年完成了系统更新,在保留核心结构的同时,新增“开放科学”模块,引入患者与公众参与、试验监查、数据共享等新条目,并对既往5个条目进行修订。本文旨在通过解析SPIRIT 2025的核心修订内容上的差异,并通过典型案例解析新报告规范在试验方案撰写中的具体应用,为国内研究者理解并落实新报告规范提供参考,提升我国临床试验方案的撰写质量。

     

    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.

     

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