[Interpretation and Examples: Key Updates in SPIRIT 2025 Statement].

Q3 Medicine

四川大学学报(医学版) Pub Date : 2025-05-20 DOI:10.12182/20250560505

Zelei Dai, Renjie Zhao, Kefan Li, Yonggang Zhang, Nian Li, Wenjie Yang, Lei Liu, Lingmin Chen

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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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[解释和示例：SPIRIT 2025声明的关键更新]。

高质量的临床试验方案是确保研究的科学完整性和伦理合规性的基石。自2013年发布以来，《标准方案项目：介入性试验建议》（SPIRIT）已成为制定临床试验方案的国际基准。为了适应开放科学的发展趋势和以患者为中心的原则，SPIRIT组在2025年完成了全面更新。更新后的指南在保留其核心结构的同时，引入了一个新的开放科学模块，并纳入了几个新元素，包括患者和公众参与、试验监测和数据共享，同时对五项已有项目进行了重大修订。在本文中，我们严格审查了SPIRIT 2025的核心修订，并通过对代表性案例研究的分析，说明了新报告指南在起草试验方案中的实际应用。我们的目标是为中国研究人员理解和实施这一新的报告指南提供有价值的参考，从而提高中国制定的临床试验方案的质量和严谨性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

四川大学学报(医学版) Biochemistry, Genetics and Molecular Biology-Molecular Biology

CiteScore

0.70

自引率

0.00%

发文量

8695

期刊介绍： "Journal of Sichuan University (Medical Edition)" is a comprehensive medical academic journal sponsored by Sichuan University, a higher education institution directly under the Ministry of Education of the People's Republic of China. It was founded in 1959 and was originally named "Journal of Sichuan Medical College". In 1986, it was renamed "Journal of West China University of Medical Sciences". In 2003, it was renamed "Journal of Sichuan University (Medical Edition)" (bimonthly). "Journal of Sichuan University (Medical Edition)" is a Chinese core journal and a Chinese authoritative academic journal (RCCSE). It is included in the retrieval systems such as China Science and Technology Papers and Citation Database (CSTPCD), China Science Citation Database (CSCD) (core version), Peking University Library's "Overview of Chinese Core Journals", the U.S. "Index Medica" (IM/Medline), the U.S. "PubMed Central" (PMC), the U.S. "Biological Abstracts" (BA), the U.S. "Chemical Abstracts" (CA), the U.S. EBSCO, the Netherlands "Abstracts and Citation Database" (Scopus), the Japan Science and Technology Agency Database (JST), the Russian "Abstract Magazine", the Chinese Biomedical Literature CD-ROM Database (CBMdisc), the Chinese Biomedical Periodical Literature Database (CMCC), the China Academic Journal Network Full-text Database (CNKI), the Chinese Academic Journal (CD-ROM Edition), and the Wanfang Data-Digital Journal Group.