眼科研究型医院是推动医学创新与成果转化的核心平台。其中，专职临床研究护士（clinical research nurse，CRN）在提升临床研究的规范性及整体质量方面发挥着不可或缺的作用。然而，当前国内尚缺乏针对眼科领域CRN管理模式的系统总结和实践指导，制约了该群体专业价值的充分发挥和制度化建设的推进。本研究以中山大学中山眼科中心（三级甲等眼科研究型医院）2013—2024年间的CRN管理实践为样本，系统梳理其管理体系的构建路径与实施成效。研究发现，通过构建“准入-培训-双轨管理”体系和实践模式，能够显著提升CRN队伍的专业能力和研究项目的整体质量。机构质控数据显示，配备CRN后的研究项目质量评分由（67.5±17.2）分显著提升至（99.3±1.0）分（P<0.001），证实了该体系的有效性和可行性。研究结果还为我国眼科临床研究护理专业化发展提供了可复制的实践模板，还进一步分析提炼出CRN的三项核心职能：一是项目管理中的流程优化，保障研究环节高效协同；二是参与者管理，强化对受试者权益的保护；三是数据质量控制，确保研究数据的准确性与完整性。在此基础上，针对当前CRN发展中普遍存在的职责不清、培训缺失、政策滞后等问题，本文还提出推动“层级化培训常态化”“政策规范细则化”等优化建议，助力我国眼科临床研究由“经验驱动”向“体系驱动”转型，为临床研究护理专业化提供实践模板和决策参考。
Ophthalmic research hospitals serve as critical platforms for advancing medical innovation and translating research outcomes into practice. Dedicated Clinical Research Nurses (CRNs) play a pivotal role in enhancing the quality, compliance, and integrity of clinical research conducted within these settings. However, in China, there remains a lack of systematic models and practical guidance for CRN management specific to the field of ophthalmology, which has hindered the full realization of their professional value and the advancement of institutionalized development. This study examined CRN management practices at Zhongshan Ophthalmic Center, Sun Yat-sen University, a Grade A tertiary ophthalmic research hospital, between 2013 and 2024 as a case example to systematically examine the development pathway and outcomes of its CRN management system. The findings demonstrate that the implementation of a standardized system encompassing entry qualifications, tiered training, and structured practice models significantly enhanced both the professional competency of CRNs and the overall quality of clinical research projects. According to institutional quality control data, the quality score of clinical research projects increased significantly from 67.5±17.2 to 99.3±1.0 (P<0.001) following the integration of CRNs. Moreover, the study identifies three core functional domains of CRNs: (1) optimizing research processes to improve project coordination and efficiency; (2) managing research participants to safeguard ethical compliance and rights protection; and (3) ensuring data quality and integrity through rigorous oversight. In response to persistent challenges such as unclear role definitions, insufficient training systems, and lagging policy support, the study proposes actionable strategies, including the institutionalization of hierarchical and continuous training as well as the refinement of policy frameworks. These findings provide a scalable and evidence-based reference for promoting the professionalization and systemic development of ophthalmic clinical research nursing in China.
目的：宏观了解2015—2020年中国眼科药物临床试验情况，为我国眼科药物的研发和临床研究提供最新数据参考，为相关决策提供依据。方法：自国家药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2015—2020年登记的眼科药物临床试验和相关试验药物信息，汇总分析眼科药物临床试验数量、试验分期、试验范围、适应证、药物类型等。结果：2015年1月1日至2020年12月31日共登记98项眼科临床试验。统计每年眼科药物临床试验登记数量，2020年登记的数量最多(28项，占28.57%)；申办方类型中，国内制药企业(75项，占76.53%)发起的眼科药物临床试验数量远高于外资制药企业(23项，占23.47%)；试验分期中，I期临床试验最多(35项，占35.71%)，III期次之(30项，占30.61%)；药物类型中，生物制品数量最多(55项，占56.12%)，化学药物次之(36项，占36.73%)。结论：近6年来，我国眼科药物临床试验进入蓬勃发展时期，尤其是眼底科领域，近2年发展迅速。在创新药领域，国内制药企业已成为眼科新药研发的中坚力量。但创新药大部分集中在眼底科领域，在青光眼、干眼等领域仍需要继续创新。
Objective: To get a macro understanding of the clinical trials of ophthalmic drugs in China from 2015 to 2020, provide the latest data reference for development of ophthalmic drugs and clinical research in China, and provide the basis for relevant decision-making. Methods: The number of clinical trials and related investigational products from 2015 to 2020 were acquired in the China Food and Drug Administration Registration and Information Disclosure Platform for Drug Clinical Studies. Characteristics on number, stage, scope, indications, type were summarized and depicted. Results: There were 98 ophthalmic clinical trials registered in China from January 1, 2015 and December 31, 2020. The year of 2020 hit the highest record of registered ophthalmic clinical trials for 28, accounting for 28.57%. Among sponsor, 75 (accounting for 76.53%) were initiated by domestic pharmaceutical enterprises, much higher than initiated by foreign pharmaceutical enterprises (23, accounting for 23.47%). Among stage, the quantity of phase I (35, accounting for 35.71%) was the largest, followed by phase III (30, accounting for 30.61%). Among type, the quantity of biological product was the largest (55, accounting for 56.12%), followed by chemical product (36, accounting for 36.73%). Conclusion: The past 6 years have seen vigorous growth of ophthalmic clinical trials, particularly in the last 2 years in the field of fundus. Domestic pharmaceutical enterprises have become the central pillar of ophthalmic drugs renovation. However, their focus is limited to fundus, innovation is still needed in areas such as glaucoma xerophthalmia.
