Ni S Q, Shen J J, Wang J Y, Fu Q B, Li C M, Qi L Y
National Clinical Trial Institute, Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou 310052, China.
Hangzhou Medical College, Hangzhou 310053, China.
Zhonghua Er Ke Za Zhi. 2021 Apr 2;59(4):299-304. doi: 10.3760/cma.j.cn112140-20200917-00880.
To evaluate the current status of the registered pediatric drug or vaccine clinical trials in China for the purpose of providing a reference for the development of pediatric clinical trials in China. We collected the data about registered pediatric clinical trials that were conducted from September 6, 2013(Mandatory registration start date) to September 6, 2019 (Cut-off date) at Chinadrugtrials.org.cn platform. The survey items included trial name and number, drug classification, sponsor's information, current trial status, completion status, etc. The clinical trials were categorized by drug group (includes chemical medicine, traditional Chinese medicine and natural medicine, biological products) and by vaccine group. During the six years 349 pediatric clinical trials were registered on the platform, including 162 pediatric drug trials and 187 vaccine trials. The numbers of chemical drugs and biological products registered in 2018 were 23 and 11, respectively, the highest in the history. The number of pediatric clinical trials of traditional Chinese medicine and natural medicine was 11 in 2014, but from 2015 to 2018 only 2 to 4 trials were registered each year. The overall completion rates of the registered drug and vaccine clinical trials were 22.8% (37/162) and 41.7%(78/187), respectively. Only 42 international multicenter pediatric clinical trial projects were registered on the platform. The numbers of drug and vaccine phase Ⅰ clinical trials were 4 and 46, respectively. Thirty-six pediatric endocrine system agent clinical trials were carried out, with the largest number of all the drug categories registered on the platform. In recent years the number of registered pediatric drug and vaccine clinical trials increased in China. However, the number is still very limited. It is urgent to further promote the development of pediatric clinical trials.
为评估我国已注册的儿科药物或疫苗临床试验的现状，为我国儿科临床试验的开展提供参考。我们收集了在“药物临床试验登记与信息公示平台”（www.chinadrugtrials.org.cn）上于2013年9月6日（强制注册起始日期）至2019年9月6日（截止日期）期间开展的已注册儿科临床试验数据。调查项目包括试验名称和编号、药物分类、申办者信息、当前试验状态、完成状态等。临床试验按药物类别（包括化学药、中药和天然药物、生物制品）和疫苗类别进行分类。在这六年中，该平台共注册了349项儿科临床试验，其中包括162项儿科药物试验和187项疫苗试验。2018年注册的化学药和生物制品数量分别为23项和11项，均创历史新高。2014年中药和天然药物儿科临床试验数量为11项，但2015年至2018年每年仅注册2至4项试验。已注册的药物和疫苗临床试验总体完成率分别为22.8%（37/162）和41.7%（78/187）。该平台仅注册了42个国际多中心儿科临床试验项目。药物和疫苗Ⅰ期临床试验数量分别为4项和46项。开展了36项儿科内分泌系统药物临床试验，是该平台注册的所有药物类别中数量最多的。近年来，我国已注册的儿科药物和疫苗临床试验数量有所增加。然而，数量仍然非常有限。迫切需要进一步推动儿科临床试验的发展。
