Laboratory Animal and Comparative Medicine ›› 2026, Vol. 46 ›› Issue (1): 138-148.DOI: 10.12300/j.issn.1674-5817.2025.056

• Guidelines for Comparative Medical Research and Reporting • Previous Articles     Next Articles

Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies

ZHENG Qingyong1,2(), ZHOU Yongjia1,2(), LI Tengfei3, XU Jianguo1,2, TIAN Chen2,4,5,6, LIU Hui1,2, TIAN Min1,2,7, ZHOU Ziyu8, XU Caihua1,2, CUI Yating1,2, WANG Junfei1,2, TIAN Jinhui1,2,9()   

  1. 1.Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, China
    2.Key Laboratory of Evidence-Based Medicine of Gansu Province, Lanzhou University, Lanzhou 730000, China
    3.School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
    4.Department of Health Policy and Management, School of Public Health, Lanzhou University, Lanzhou 730000, China
    5.Laboratory of Cross-Innovation for Evidence-based Social Sciences, Lanzhou University, Lanzhou 730000, China
    6.Research Centre for Health Management and Health Development, Lanzhou University, Lanzhou 730000, China
    7.Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730000, China
    8.The Second Clinical Medical School, Lanzhou University, Lanzhou 730030, China
    9.Research Unit of Evidence-Based Evaluation and Guidelines, Chinese Academy of Medical Sciences, Lanzhou 730000, China
  • Received:2025-04-23 Revised:2025-08-20 Online:2026-02-25 Published:2026-02-14
  • Contact: TIAN Jinhui

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Abstract:

Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.

Key words: Animal experimentation, Core outcome set, Standardization, Evidence integration, Research methodology

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