Abstract: In April 2025, leading international medical journals such as BMJ, JAMA, and Lancet simultaneously released the updated SPIRIT 2025 statement. This statement is an internationally recognized guidance framework for the development and reporting of clinical trial protocols, aiming to enhance the scientific rigor, transparency, and ethical standards of clinical trial protocols, thereby promoting higher quality and more standardized medical research worldwide. Compared to the SPIRIT 2013, the SPIRIT 2025 statement added two new items, revised five items, deleted three items, and merged two items. Additionally, the overall structure of the checklist was also reorganized, integrating items on trial registration, protocols and statistical analysis plans, data sharing, funding and conflicts of interest, and publication policies into a single open science section. Open science is not merely a technical or policy provision, but a spiritual pursuit embedded in the ethics and values of the scientific community. Achieving open science requires seamless communication at multiple levels, including scientific dissemination, data openness, and method sharing. This article elucidates the definition, historical development, and challenges of open science, enabling readers to deeply understand, support, and participate in open science initiatives in the development of clinical trial protocols.

Key words: Open science; Randomised trial; Clinical trial protocol; Guideline

摘要： 2025年4月，全球顶级医学期刊（如BMJ、JAMA、Lancet等）同步发布更新版SPIRIT 2025声明。该声明是国际公认的临床试验方案制订与报告指导框架，其目的在于提高临床试验方案的科学性、透明度及伦理标准，从而推动全球范围内的医学研究达到更高质量和更为统一的规范水平。相较于SPIRIT 2013，SPIRIT 2025声明新增2个条目，修订5个条目，删除3个条目，合并2个条目。此外，该声明还进行了整体结构调整，将试验注册、方案和统计分析计划、数据共享、资金来源与利益冲突、发表政策等条目整合为开放科学章节。开放科学不仅是技术或政策条款，更是融入科学共同体伦理和价值观的精神追求。开放科学的实现需要在科学传播、数据开放和方法共享等多层面上确保信息畅通。本文通过阐述开放科学的定义、发展历史及面临的挑战，旨在帮助读者深刻理解、支持和推动临床试验方案制订过程中的开放科学举措。

关键词: 开放科学; 随机试验; 临床试验方案; 指南