Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval
Abstract Background Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric...
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| Format: | Article |
| Language: | English |
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BMC
2022-03-01
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| Series: | BMC Pediatrics |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12887-022-03208-2 |
| _version_ | 1818315530504765440 |
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| author | Lin Song Yuntao Jia Sujuan Ran Bin Li Jin Xu Bennian Huo Nange Yin Maolin Ai Yao Liu |
| author_facet | Lin Song Yuntao Jia Sujuan Ran Bin Li Jin Xu Bennian Huo Nange Yin Maolin Ai Yao Liu |
| author_sort | Lin Song |
| collection | DOAJ |
| description | Abstract Background Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric clinical trials conducted in China to provide reference for research and development of pediatric drugs and formulation of relevant policies. Methods We conducted a cross-sectional observational study of pediatric trials registered in the Drug Trial Registration and Information Publication Platform before Oct. 31, 2021. All trials that recruited children (under 18 years old as defined in China) were retrieved and general characteristics of the trials and the research drugs were extracted and analyzed. The data were extracted and statistically analyzed by excel 2010 and SPSS 22.0, respectively. Results There were 588 registered pediatric clinical trials, which accounted for 3.94% of the total registered trials. The overall average annual growth rate of the number of trials from 2013 to 2020 was 14.47% (P < 0.01). Of the 588 trials included, there were 312 trials (53.06%) with only children as subjects, 127 trials (21.60%) with research drugs only for children use, and the median of target subject number was 320 with the range of 8 to 600,000. The sponsors and the principal investigators were mainly located in the eastern and northern China. 325 trials were vaccine trials, and the dosage form was mainly injection. There were 98 non-vaccine biological product trials (mainly injections), 135 chemical compound drug trials (mainly tablets), 30 traditional Chinese medicine/natural drugs (mainly granules). Indications of the non-vaccine drugs were mainly diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Conclusion The number of pediatric clinical trials in China has increased these years. To further promote pediatric clinical trials and motivate pediatric appropriate drug marketing application and administrative approval, conducting large pediatric clinical trials, further development of dosage forms suitable for children with special attention to neonates and prematurity, and improving uneven geographical distribution of sponsors and researchers are the current challenges. |
| first_indexed | 2024-12-13T09:07:00Z |
| format | Article |
| id | doaj.art-6e16eed57f164da99c3b422654be51dc |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-13T09:07:00Z |
| publishDate | 2022-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-6e16eed57f164da99c3b422654be51dc2022-12-21T23:53:02ZengBMCBMC Pediatrics1471-24312022-03-012211910.1186/s12887-022-03208-2Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approvalLin Song0Yuntao Jia1Sujuan Ran2Bin Li3Jin Xu4Bennian Huo5Nange Yin6Maolin Ai7Yao Liu8Department of Pharmacy, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical UniversityDepartment of Pharmacy, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical UniversityDepartment of Pharmacy, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical UniversityDepartment of Pharmacy, Daping Hospital, Army Medical UniversityDepartment of Pharmacy, Daping Hospital, Army Medical UniversityDepartment of Pharmacy, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical UniversityDepartment of Pharmacy, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical UniversityDepartment of Pharmacy, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation base of Child development and Critical Disorders, Children’s Hospital of Chongqing Medical UniversityDepartment of Pharmacy, Daping Hospital, Army Medical UniversityAbstract Background Research and development of pediatric drug faces many difficulties and pediatric clinical trials remain a challenge. Since 2011, a series of measures have been taken to encourage research, development of drugs for pediatric patients in China. In this study, we analyzed pediatric clinical trials conducted in China to provide reference for research and development of pediatric drugs and formulation of relevant policies. Methods We conducted a cross-sectional observational study of pediatric trials registered in the Drug Trial Registration and Information Publication Platform before Oct. 31, 2021. All trials that recruited children (under 18 years old as defined in China) were retrieved and general characteristics of the trials and the research drugs were extracted and analyzed. The data were extracted and statistically analyzed by excel 2010 and SPSS 22.0, respectively. Results There were 588 registered pediatric clinical trials, which accounted for 3.94% of the total registered trials. The overall average annual growth rate of the number of trials from 2013 to 2020 was 14.47% (P < 0.01). Of the 588 trials included, there were 312 trials (53.06%) with only children as subjects, 127 trials (21.60%) with research drugs only for children use, and the median of target subject number was 320 with the range of 8 to 600,000. The sponsors and the principal investigators were mainly located in the eastern and northern China. 325 trials were vaccine trials, and the dosage form was mainly injection. There were 98 non-vaccine biological product trials (mainly injections), 135 chemical compound drug trials (mainly tablets), 30 traditional Chinese medicine/natural drugs (mainly granules). Indications of the non-vaccine drugs were mainly diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism. Conclusion The number of pediatric clinical trials in China has increased these years. To further promote pediatric clinical trials and motivate pediatric appropriate drug marketing application and administrative approval, conducting large pediatric clinical trials, further development of dosage forms suitable for children with special attention to neonates and prematurity, and improving uneven geographical distribution of sponsors and researchers are the current challenges.https://doi.org/10.1186/s12887-022-03208-2Pediatric patientsClinical trialsDrugDosage formDrug Trial Registration and Information Publication Platform |
| spellingShingle | Lin Song Yuntao Jia Sujuan Ran Bin Li Jin Xu Bennian Huo Nange Yin Maolin Ai Yao Liu Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval BMC Pediatrics Pediatric patients Clinical trials Drug Dosage form Drug Trial Registration and Information Publication Platform |
| title | Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval |
| title_full | Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval |
| title_fullStr | Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval |
| title_full_unstemmed | Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval |
| title_short | Current situation of pediatric clinical trials in China: focus on trials for drug marketing application and administrative approval |
| title_sort | current situation of pediatric clinical trials in china focus on trials for drug marketing application and administrative approval |
| topic | Pediatric patients Clinical trials Drug Dosage form Drug Trial Registration and Information Publication Platform |
| url | https://doi.org/10.1186/s12887-022-03208-2 |
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