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ORIGINAL RESEARCH article

Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1409270

Discussion on Classification of Pediatric Drug Clinical Trials in Children's Hospital in China

Provisionally accepted
Yong Yang Yong Yang 1,2*Rui Jiang Rui Jiang 2*Gengliang Bai Gengliang Bai 2*Qingqing Liu Qingqing Liu 3*Yongfa Chen Yongfa Chen 4*
  • 1 School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China
  • 2 Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
  • 3 Nanjing Children's Hospital, Nanjing, Jiangsu Province, China
  • 4 China Pharmaceutical University, Nanjing, Jiangsu Province, China

The final, formatted version of the article will be published soon.

    Objectives：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 as well as research and development of pediatric drugs. Methods：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 old, including those conducted in children's hospitals. The retrieval period extended until December 31, 2022.Results：A total of 459 pediatric clinical trials were collected, comprising 299 from Chi CTR and 160 from the information platform. Postmarketing 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, as well as nutritional or metabolic diseases. Chemical drugs constituted the most extensively studied category while traditional Chinese medicine/natural drugs received comparatively less attention. Geographically, clinical trial activities were primarily concentrated in eastern coastal regions of China with multi-center trials being predominant. Ethics committee approval was obtained for 427 studies. Conclusions：T 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 observed. 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 investigative children's hospitals will contribute to promoting highquality development of children's health in China.

    Keywords: Pediatric drug1, clinical trials2, Children's hospital3, Drug research4, Children's medicine5, Clinical research6

    Received: 17 Apr 2024; Accepted: 14 Jun 2024.

    Copyright: © 2024 Yang, Jiang, Bai, Liu and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Yong Yang, School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China
    Rui Jiang, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
    Gengliang Bai, Nanjing University of Chinese Medicine, Nanjing, Jiangsu Province, China
    Qingqing Liu, Nanjing Children's Hospital, Nanjing, Jiangsu Province, China
    Yongfa Chen, China Pharmaceutical University, Nanjing, 210009, Jiangsu Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.