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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Frontiers Media S.A.
2023-07-01
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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. |
first_indexed | 2024-03-13T00:56:30Z |
format | Article |
id | doaj.art-dfc50d3053bf4bf288507b08587642a5 |
institution | Directory Open Access Journal |
issn | 2296-858X |
language | English |
last_indexed | 2024-03-13T00:56:30Z |
publishDate | 2023-07-01 |
publisher | Frontiers Media S.A. |
record_format | Article |
series | Frontiers in Medicine |
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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