Construction and Thinking of Pediatric Clinical Trial Training System
- VernacularTitle:儿科人群药物临床试验培训体系的构建与思考
- Author:
Shirong PENG
1
;
Qian WANG
2
;
Haiyan CHEN
1
;
Shuli MA
1
;
Xiaoling WANG
2
Author Information
1. Dept. of Pharmacy，Children’s Hospital Affiliated to Zhengzhou University/Henan Children’s Hospital/Zhengzhou Children’s Hospital，Zhengzhou 450018，China
2. Clinical Research Center，Beijing Children’s Hospital Affiliated to Capital Medical University/National Center for Children’s Health，Beijing 100045，China
- Publication Type:Journal Article
- Keywords:
Pediatric;
Drug clinical trial;
Training system;
Establishment
- From:
China Pharmacy
2019;30(11):1441-1444
- CountryChina
- Language:Chinese
-
Abstract:
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.
