儿科人群药物临床试验培训体系的构建与思考

目的:提高儿科人群药物临床试验质量,构建儿科人群药物临床试验培训体系。方法:通过查阅文献,参考美国和欧盟药物临床试验培训体系(主要包括发起方、培训对象、培训内容和时间、培训方式和考核方式等内容),结合我国儿科人群药物临床试验特点,构建我国儿科人群药物临床试验培训体系。结果与结论:美国和欧盟药物临床试验培训体系较为完善,以美国为例,美国药物临床试验由美国国立卫生研究院(NIH)发起,主要针对临床研究员和其他从事临床研究的卫生技术人员,培训内容包括药理学、临床研究原理与实践、生物伦理学等,通常未注明学习时间,培训方式主要包括远程教育和在线网络培训,并通过在线网络考试进行考核。笔者建议建立中国儿科人群药物临床试验协作网,针对临床研究人员开发分层次分级别(如设置基础班、提升班、高级班)的培训课程并设置相应时间(分别设置2、3、4 d),设置多样化的培训方式(如在线、面授、外派等)并创新考核方式(改为面对面考核并制订统一的考核标准),通过以上方式逐步构建和完善我国儿科人群药物临床试验培训体系。

Construction and Thinking of Pediatric Clinical Trial Training System

OBJECTIVE:To improve the quality of pediatric clinical trials,and establish the clinical trial training system for pediatric. METHODS:By consulting the literature,referring to the clinical research and training system of the United States and the European Union(mainly including initiators,training objects,training contents and time,training methods and assessment methods),and combining with the characteristics of pediatric clinical trials in China,the pediatric clinical trial training system was built. RESULTS & CONCLUSIONS:The training system of clinical drug trials in the United States and the European Union is relatively perfect. Taking the United States as an example,clinical drug trials in the United States were initiated by the National Institutes of Health(NIH),mainly for clinical researchers and other health technicians engaged in clinical research. The training contents included pharmacology,clinical research principle and practice,bioethics,etc. The training time was usually not indicated. The main methods included distance education and online network training,and assessment through online network examination. The author suggests that a collaborative network of pediatric clinical trials should be established in China. For clinical researchers,training courses should be developed at different levels(e.g. basic classes,promotion classes,advanced classes)and corresponding time should be set up(e.g. 2,3,4 d). Various training methods should be set up(e.g. online,face-to-face, assignment,etc.)and assessment methods should changed(be changed to face-to-face assessment and formulate unified assessment criteria). The training system of pediatric drug clinical trials in China can be gradually built and improved through the above ways.