新临床试验立项前既有证据的快速审查:REVEAL指南解读及中国应用建议

Rapid Assessment of Prior Evidence Before Initiating New Clinical Trials: Interpretation of the REVEAL Guidance and Recommendations for Application in China

  • 摘要: 临床试验立项前审查既有证据,有助于评估研究必要性、减少不必要的重复研究并优化试验设计,但完整系统评价常受时间、人员和方法学能力限制。2026年,BMJ发表的新试验既有证据审查(prior evidence for new trials,REVEAL)指南提出优先检索系统评价、必要时再检索已发表、未发表及进行中试验的两阶段流程,并配套结构化报告表。本文解读REVEAL的方法学定位、核心流程及新试验必要性判断依据,重点归纳证据复用、按需推进、限定更新时段和任务分层等提速机制,结合原指南示例说明应用要点,并分析其局限与误用风险。在此基础上,结合我国文献环境和研究管理需要,提出补充中文文献与注册信息、按研究风险配置人员和审查强度、将审查结果用于伦理审查、基金申请及试验方案论证、开展本土试点等应用建议。REVEAL可为资源受限团队提供可操作的立项前证据审查路径,但其简化审查结果不应等同于完整系统评价结论,本土适用性及对研究决策的实际影响仍需验证。

     

    Abstract: Reviewing existing evidence before initiating a clinical trial helps assess the necessity of the study, reduce unnecessary duplication, and optimize trial design; however, conducting a full systematic review is often constrained by time, personnel, and methodological capacity. In 2026, BMJ published the prior evidence for new trials (REVEAL) guidance, which proposes a two-stage process that prioritizes searching for systematic reviews and, when necessary, proceeds to search published, unpublished, and ongoing trials, accompanied by a structured reporting template. This article interprets REVEAL’s methodological positioning, core workflow, and the basis for determining the necessity of a new trial. It highlights time-saving mechanisms, including evidence reuse, need-based progression, restricted update windows, and task stratification, and illustrates key application points using a worked example from the original guidance. It also analyzes the guidance’s limitations and risks of misuse. On this basis, and in light of China’s literature environment and research management needs, we propose application recommendations: supplementing Chinese-language literature and registry information, aligning personnel and review intensity with trial risk, using review results for ethics review, funding applications, and trial protocol justification, and conducting local pilot evaluations. REVEAL provides an actionable pre-initiation evidence review pathway for resource-limited teams; however, its simplified review findings should not be equated with the conclusions of a full systematic review, and its local applicability and actual impact on research decisions require further validation.

     

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