Trends in innovative pediatric drug development in China based on clinical trial registration data

In China, the focus of drug research and development has gradually shifted from generic to innovative drugs. Using the Chinese Clinical Trials Registry and Information Transparency Platform, we retrospectively analyzed clinical trials of innovative pediatric drugs conducted in mainland China over th...

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Main Authors: Wen-Wen Wu, Xing Ji, Xin-Shuang Mou, Xin-Yue Ma, Ya-Ting Huang, Jie-Ying Zhang, Jing-Xian Zhang, Xin-Rong Xie, Ning-Ying Mao, Jing Xu
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-07-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2023.1187547/full
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author Wen-Wen Wu
Wen-Wen Wu
Xing Ji
Xin-Shuang Mou
Xin-Yue Ma
Ya-Ting Huang
Jie-Ying Zhang
Jing-Xian Zhang
Xin-Rong Xie
Ning-Ying Mao
Ning-Ying Mao
Ning-Ying Mao
Jing Xu
author_facet Wen-Wen Wu
Wen-Wen Wu
Xing Ji
Xin-Shuang Mou
Xin-Yue Ma
Ya-Ting Huang
Jie-Ying Zhang
Jing-Xian Zhang
Xin-Rong Xie
Ning-Ying Mao
Ning-Ying Mao
Ning-Ying Mao
Jing Xu
author_sort Wen-Wen Wu
collection DOAJ
description In China, the focus of drug research and development has gradually shifted from generic to innovative drugs. Using the Chinese Clinical Trials Registry and Information Transparency Platform, we retrospectively analyzed clinical trials of innovative pediatric drugs conducted in mainland China over the last decade. The goal of this work was to better understand the characteristics of and historical changes in innovative pediatric drug research and development (R&D) in China and to provide effective data support for policy makers and other stakeholders. This study included 198 innovative pediatric drug clinical trials. The data showed that, although some progress has been made in the R&D of innovative pediatric drugs in China, many factors limiting this progress still exist, such as concentrated R&D areas, inadequate pediatric participants, and unbalanced source distributions. The level of innovative pediatric drug R&D in China currently lags behind the global level and has not kept pace with anti-neoplastic drug R&D in China. To promote the innovative development of pediatric drugs in China, the Chinese government must develop an R&D supervision framework, improve the motivation and innovation capabilities of pharmaceutical companies, and optimize the source distribution between regions.
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spelling doaj.art-dfc50d3053bf4bf288507b08587642a52023-07-06T20:58:14ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2023-07-011010.3389/fmed.2023.11875471187547Trends in innovative pediatric drug development in China based on clinical trial registration dataWen-Wen Wu0Wen-Wen Wu1Xing Ji2Xin-Shuang Mou3Xin-Yue Ma4Ya-Ting Huang5Jie-Ying Zhang6Jing-Xian Zhang7Xin-Rong Xie8Ning-Ying Mao9Ning-Ying Mao10Ning-Ying Mao11Jing Xu12School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaDepartment of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaDepartment of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaSchool of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, Jiangsu, ChinaInstitute of Regulatory Science of China Pharmaceutical University, Nanjing, Jiangsu, ChinaNational Medical Products Administration Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing, Liaoning, ChinaDepartment of Pharmacy, Children’s Hospital of Nanjing Medical University, Nanjing, Jiangsu, ChinaIn China, the focus of drug research and development has gradually shifted from generic to innovative drugs. Using the Chinese Clinical Trials Registry and Information Transparency Platform, we retrospectively analyzed clinical trials of innovative pediatric drugs conducted in mainland China over the last decade. The goal of this work was to better understand the characteristics of and historical changes in innovative pediatric drug research and development (R&D) in China and to provide effective data support for policy makers and other stakeholders. This study included 198 innovative pediatric drug clinical trials. The data showed that, although some progress has been made in the R&D of innovative pediatric drugs in China, many factors limiting this progress still exist, such as concentrated R&D areas, inadequate pediatric participants, and unbalanced source distributions. The level of innovative pediatric drug R&D in China currently lags behind the global level and has not kept pace with anti-neoplastic drug R&D in China. To promote the innovative development of pediatric drugs in China, the Chinese government must develop an R&D supervision framework, improve the motivation and innovation capabilities of pharmaceutical companies, and optimize the source distribution between regions.https://www.frontiersin.org/articles/10.3389/fmed.2023.1187547/fullpediatric populationinnovative pediatric drugclinical trialChinese Clinical Trials Registry and Information Transparency Platformresearch and development
spellingShingle Wen-Wen Wu
Wen-Wen Wu
Xing Ji
Xin-Shuang Mou
Xin-Yue Ma
Ya-Ting Huang
Jie-Ying Zhang
Jing-Xian Zhang
Xin-Rong Xie
Ning-Ying Mao
Ning-Ying Mao
Ning-Ying Mao
Jing Xu
Trends in innovative pediatric drug development in China based on clinical trial registration data
Frontiers in Medicine
pediatric population
innovative pediatric drug
clinical trial
Chinese Clinical Trials Registry and Information Transparency Platform
research and development
title Trends in innovative pediatric drug development in China based on clinical trial registration data
title_full Trends in innovative pediatric drug development in China based on clinical trial registration data
title_fullStr Trends in innovative pediatric drug development in China based on clinical trial registration data
title_full_unstemmed Trends in innovative pediatric drug development in China based on clinical trial registration data
title_short Trends in innovative pediatric drug development in China based on clinical trial registration data
title_sort trends in innovative pediatric drug development in china based on clinical trial registration data
topic pediatric population
innovative pediatric drug
clinical trial
Chinese Clinical Trials Registry and Information Transparency Platform
research and development
url https://www.frontiersin.org/articles/10.3389/fmed.2023.1187547/full
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