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| 儿科药物临床试验研究者培训现状与需求调研———基于某三甲儿童 医院数据 |
| 樊文香1,吴乐盈2,李吉1,王瑞1,李春梅1,倪韶青1,徐驰3 |
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| (1. 浙江大学医学院附属儿童医院,儿童少年健康与疾病国家 临床医学研究中心,杭州 310052;2. 杭州医学院,杭州 310053;3. 浙江中医药大学,杭州 310053) |
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| 摘要: |
| 目的:基于某三甲医院儿科药物临床试验研究者的能力培训现状与核心需求,为构建系统化、针对性的研究者培训体系 提供参考。 方法:对某三甲医院儿科药物临床试验研究者进行横断面调查。 分析其培训现状、能力自评、工作难点及培训需求 等情况。 结果:当前研究者培训在体系完整性、儿科特色内容深度及实践支持方面存在不足。 多数研究者接受的培训频率不固 定,内容与形式较为单一。 研究者普遍反映在不良事件处理、伦理审查及数据质量管控等方面面临挑战,并对系统化、分角色的 专项能力提升培训表现出强烈意愿。 对培训模式、考核方式及激励措施等方面亦提出明确需求。 结论:未来应围绕儿科试验特 点,构建分层分类、理论与实践相结合的规范化培训体系,并完善考核反馈与激励机制,以系统性提升研究者胜任力,保障临床 试验质量。 |
| 关键词: 儿科 药物临床试验 研究者 需求 培训体系 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2026.03.001 |
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| 基金项目:国家重点研发计划资助项目,编号 2023YFC2706100;国家自然科学基金面上项目,编号 82373971;浙江省“尖兵” “领雁”研发攻 关计划资助项目,编号 2023C03003;浙江省医药卫生科技计划项目,编号 2025KY985。 |
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| Current Status and Needs of Training for Researchers in Pediatric Drug Clinical Trials: Based on the Data of a Grade Ⅲ, Level A Children’s Hospital |
| Fan Wenxiang1 , Wu Leying2 , Li Ji1 , Wang Rui1 , Li Chunmei1 , Ni Shaoqing1 , Xu Chi3 |
| (1. Children’ s Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Children and Adolescents’ Health and Diseases, Hangzhou 310052, China; 2. Hangzhou Medical College, Hangzhou 310053, China; 3. Zhejiang Chinese Medical University, Hangzhou 310053, China) |
| Abstract: |
| Objective: Based on the current status and core needs of training for researchers in pediatric drug clinical trials in a grade Ⅲ, level A hospital, and to provide basis for the construction of systematic and targeted researcher training system. Methods: A cross- sectional survey was performed among the researchers of pediatric drug clinical trials in a grade Ⅲ, level A hospital. The training status, self-assessment competency, work-related challenges, and training needs were evaluated. Results: The current training for researchers was found to be inadequate in terms of systemic integrity, depth of pediatric-specific content, and practical support. Most researchers participated in training at irregular intervals, with limited variety in both content and format. Commonly reported challenges included the management of adverse events, ethical review processes, and data quality control. Researchers expressed a strong need for systematic, role-specific training to enhance specialized competencies. Clear expectations were also indicated regarding training models, assessment methods, and incentive measures. Conclusion: There is a need to develop a standardized training system tailored to the characteristics of pediatric clinical trials. This system should incorporate a stratified and categorized structure, integrate theoretical and practical components, and establish improved assessment feedback and incentive mechanisms. Such an approach would systematically enhance the competency of researchers and contribute to the assurance of clinical trial quality. |
| Key words: Pediatrics drug clinical trials researchers needs training system |
