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Comparative study on the management of pediatric clinical trials between China and America
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Yi-ming ZHONG, Tian-yi ZHANG, Wen GUO
Chinese Journal of New Drugs | 2021, 30(14) : 1302 - 1308
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收藏切换
Chinese Journal of New Drugs | 2021, 30(14): 1302-1308
Comparative study on the management of pediatric clinical trials between China and America
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Yi-ming ZHONG, Tian-yi ZHANG, Wen GUO
Affiliations
  • China National Pharmaceutical Industry Information Center, China State Institute of Pharmaceutical Industry, Shanghai 200040, China
Published: 2021-07-30
Outline
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A pediatric clinical trial is a systematic study of a drug in people aged 0~18 years. Due to the specialness of the subjects, the process management of pediatric clinical trial is particularly important. Whether a high-quality pediatric clinical trial can be carried out directly affects the marketing speed of pediatric drugs, and then affects the accessibility of pediatric drugs. At present, there are still some problems in pediatric clinical trials in China, such as difficulty in recruiting subjects, lack of high-quality standard management in the trial process, and lack of rigor in the ethical review. Based on a comprehensive analysis of the policies, measures and regulatory experience in promoting the development of pediatric clinical trials in the United States, this paper compared the relevant policies and regulatory systems of pediatric clinical trials in China with those in the United States, and analyzed the problems existing in the management of pediatric clinical trials in China, so as to propose countermeasures and suggestions for improving our management of pediatric clinical trials.

pediatric drugs  /  clinical trials  /  policies and regulations  /  regulatory
钟一鸣, 张天义, 郭文. 中美儿科临床试验管理的比较研究. 中国新药杂志, 2021 , 30 (14) : 1302 -1308 .
Yi-ming ZHONG, Tian-yi ZHANG, Wen GUO. Comparative study on the management of pediatric clinical trials between China and America[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1302 -1308 .
Year 2021 volume 30 Issue 14
48
8
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  • Online Date:2026-10-28
  • Published:2021-07-30
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  • Accepted:2021-05-17
Affiliations
    China National Pharmaceutical Industry Information Center, China State Institute of Pharmaceutical Industry, Shanghai 200040, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)
属
Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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