■本研究旨在深入了解在中国儿童医院开展的儿科临床试验，为儿童医院的发展和儿科药物的研发提供有价值的参考。
■对中国临床试验注册中心（ChiCTR）和ChinaDrugTrials.org进行了全面搜索。cn收集所有涉及18岁以下受试者的临床试验信息，包括在儿童医院进行的那些。检索期延长至2022年12月31日。
■共收集了459项儿科临床试验，包括来自ChiCTR的299个和来自药物临床试验注册和信息公开平台（信息平台）的160个。上市后药物研究和III期临床试验占研究阶段的大部分。这些试验涵盖了广泛的疾病/系统，特别关注呼吸系统疾病，肿瘤，内分泌失调,营养或代谢疾病。化学药物构成了研究最广泛的类别，而中药/天然药物受到的关注相对较少。临床试验活动主要集中在中国东部沿海地区，多中心试验是最主要的。427项研究获得了伦理委员会的批准。
■中国儿童医院进行的儿科临床试验总体呈上升趋势，专注于中医的研究有限，以及严重的区域和体制失衡。此外，道德审查程序仍有改进的空间。建议儿童医院在提高科研能力的同时,优化资源配置,有效满足医疗服务需求。此外,培育更多专注于研究的儿童医院将有助于中国儿童健康的高质量发展。
UNASSIGNED: This study aimed to gain insights into pediatric clinical trials conducted in children\'s hospitals in
China and provide valuable references for the development of children\'s hospitals and the research and development of pediatric drugs.
UNASSIGNED: A comprehensive search was performed on the Chinese Clinical Trial Registry (Chi CTR) and ChinaDrugTrials.org.cn to collect information on all clinical trials involving subjects under 18 years, including those conducted in children\'s hospitals. The retrieval period was extended until 31 December 2022.
UNASSIGNED: A total of 459 pediatric clinical trials were collected, comprising 299 from Chi CTR and 160 from the Drug Clinical Trial Registration and Information Publicity Platform (Information Platform). Post-marketing drug studies and phase III clinical trials accounted for the majority of research stages. These trials covered a wide range of diseases/systems, with a particular focus on respiratory system disorders, tumors, endocrine disorders, and nutritional or metabolic diseases. Chemical drugs constituted the most extensively studied category, while traditional Chinese medicine/natural drugs received comparatively less attention. Clinical trial activities were primarily geographically focused on the eastern coastal regions of
China, with multicenter trials being the most predominant. Ethics committee approval was obtained for 427 studies.
UNASSIGNED: The pediatric clinical trials conducted by children\'s hospitals in
China have shown an overall upward trend; however, there is limited research focusing on traditional Chinese medicine, along with significant regional and institutional imbalances. Furthermore, there is still room for improvement regarding ethical review processes. It is recommended that children\'s hospitals enhance their scientific research capabilities while optimizing resource allocation to meet medical service demands effectively. Additionally, fostering more research-focused children\'s hospitals will contribute to the high-quality development of children\'s health in
China.
PDF(Pubmed)