Analysis of the progress of clinical trials for ophthalmic drug in China, 2022
AIM: To explore the progress of clinical trials for ophthalmic drugs in China in 2022 and discuss its changes with 2014 to 2021, thus providing the latest data reference for the development of new drug and the implementation of clinical trials, and a basis for decision-making.METHODS: In this cross-...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Press of International Journal of Ophthalmology (IJO PRESS)
2023-07-01
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| Series: | Guoji Yanke Zazhi |
| Subjects: | |
| Online Access: | http://ies.ijo.cn/cn_publish/2023/7/202307032.pdf |
| _version_ | 1797783277026672640 |
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| author | Jian-Ping Hu Lin Zhang Chen Xin Chu-Zhi Peng Yong-Hong Jiao |
| author_facet | Jian-Ping Hu Lin Zhang Chen Xin Chu-Zhi Peng Yong-Hong Jiao |
| author_sort | Jian-Ping Hu |
| collection | DOAJ |
| description | AIM: To explore the progress of clinical trials for ophthalmic drugs in China in 2022 and discuss its changes with 2014 to 2021, thus providing the latest data reference for the development of new drug and the implementation of clinical trials, and a basis for decision-making.METHODS: In this cross-sectional study, we retrieved the drug clinical trials registration and information disclosure platform of National Medical Products Administration database. Drug clinical trials for eye diseases registered from January 1 to December 31, 2022 were included. Number(proportion)was used to describe the characteristics of clinical trials for ophthalmic drug, the indication, the trial phase, the efficacy and the geographical distribution.RESULTS:A total of 55 clinical trials for ophthalmic drug were included, which accounted for 1.66% of all clinical trials, showing a steady growth trend. Main drug type was chemical drugs with the highest proportion of 58.18%. The top three indications with the most clinical trials were age-related macular degeneration, myopia and dry eye. Two gene drugs emerged in 2022, and 7 drugs carried out ≥2 trials, of which atropine sulfate and recombinant anti-vascular endothelial growth factor(VEGF)humanized monoclonal antibody were the most(7 and 5 respectively). Most trials were in phase I and phase III stages, accounting for 36.36% and 27.27% respectively. The median start-up time of phase I trials in 2022 was 2.72(0.77, 3.47)mo, which was significantly shorter than 3.87(3.00, 6.30)mo of 2014～2021(Z=-2.630, P=0.009), and there were no significant differences between BE, phase II, III, IV comparing with 2014～2021(P>0.05).CONCLUSIONS: In 2022, the number and implementation efficiency of clinical trials for ophthalmic drugs in China increased steadily. The indications are mainly fundus disease, myopia and dry eye. Most new drugs are in the early stage of research and development or close to market. Gene therapy drugs began to emerge. |
| first_indexed | 2024-03-13T00:23:46Z |
| format | Article |
| id | doaj.art-fd762c1deb924886b8a5de9a13a1782b |
| institution | Directory Open Access Journal |
| issn | 1672-5123 |
| language | English |
| last_indexed | 2024-03-13T00:23:46Z |
| publishDate | 2023-07-01 |
| publisher | Press of International Journal of Ophthalmology (IJO PRESS) |
| record_format | Article |
| series | Guoji Yanke Zazhi |
| spelling | doaj.art-fd762c1deb924886b8a5de9a13a1782b2023-07-11T08:08:47ZengPress of International Journal of Ophthalmology (IJO PRESS)Guoji Yanke Zazhi1672-51232023-07-012371225122910.3980/j.issn.1672-5123.2023.7.32202307032Analysis of the progress of clinical trials for ophthalmic drug in China, 2022Jian-Ping Hu0Lin Zhang1Chen Xin2Chu-Zhi Peng3Yong-Hong Jiao4Beijing Tongren Hospital, Capital Medical University;Beijing Tongren Eye Center;Beijing Institute of Ophthalmology;Beijing Key Laboratory of Ophthalmology & Visual Sciences, Beijing 100730, ChinaInstitute of Artificial Intelligence, Hefei Comprehensive National Science Center;Anhui Artificial Intelligence Laboratory, Hefei 230001, Anhui Province, ChinaBeijing Tongren Hospital, Capital Medical University;Beijing Tongren Eye Center;Beijing Institute of Ophthalmology;Beijing Key Laboratory of Ophthalmology & Visual Sciences, Beijing 100730, ChinaBeijing Tongren Hospital, Capital Medical University;Beijing Tongren Eye Center;Beijing Institute of Ophthalmology;Beijing Key Laboratory of Ophthalmology & Visual Sciences, Beijing 100730, ChinaBeijing Tongren Hospital, Capital Medical University;Beijing Tongren Eye Center;Beijing Institute of Ophthalmology;Beijing Key Laboratory of Ophthalmology & Visual Sciences, Beijing 100730, ChinaAIM: To explore the progress of clinical trials for ophthalmic drugs in China in 2022 and discuss its changes with 2014 to 2021, thus providing the latest data reference for the development of new drug and the implementation of clinical trials, and a basis for decision-making.METHODS: In this cross-sectional study, we retrieved the drug clinical trials registration and information disclosure platform of National Medical Products Administration database. Drug clinical trials for eye diseases registered from January 1 to December 31, 2022 were included. Number(proportion)was used to describe the characteristics of clinical trials for ophthalmic drug, the indication, the trial phase, the efficacy and the geographical distribution.RESULTS:A total of 55 clinical trials for ophthalmic drug were included, which accounted for 1.66% of all clinical trials, showing a steady growth trend. Main drug type was chemical drugs with the highest proportion of 58.18%. The top three indications with the most clinical trials were age-related macular degeneration, myopia and dry eye. Two gene drugs emerged in 2022, and 7 drugs carried out ≥2 trials, of which atropine sulfate and recombinant anti-vascular endothelial growth factor(VEGF)humanized monoclonal antibody were the most(7 and 5 respectively). Most trials were in phase I and phase III stages, accounting for 36.36% and 27.27% respectively. The median start-up time of phase I trials in 2022 was 2.72(0.77, 3.47)mo, which was significantly shorter than 3.87(3.00, 6.30)mo of 2014～2021(Z=-2.630, P=0.009), and there were no significant differences between BE, phase II, III, IV comparing with 2014～2021(P>0.05).CONCLUSIONS: In 2022, the number and implementation efficiency of clinical trials for ophthalmic drugs in China increased steadily. The indications are mainly fundus disease, myopia and dry eye. Most new drugs are in the early stage of research and development or close to market. Gene therapy drugs began to emerge.http://ies.ijo.cn/cn_publish/2023/7/202307032.pdfdrug clinical trialsophthalmologyclinical trialsdrugchinaage-related macular degenerationmyopia |
| spellingShingle | Jian-Ping Hu Lin Zhang Chen Xin Chu-Zhi Peng Yong-Hong Jiao Analysis of the progress of clinical trials for ophthalmic drug in China, 2022 Guoji Yanke Zazhi drug clinical trials ophthalmology clinical trials drug china age-related macular degeneration myopia |
| title | Analysis of the progress of clinical trials for ophthalmic drug in China, 2022 |
| title_full | Analysis of the progress of clinical trials for ophthalmic drug in China, 2022 |
| title_fullStr | Analysis of the progress of clinical trials for ophthalmic drug in China, 2022 |
| title_full_unstemmed | Analysis of the progress of clinical trials for ophthalmic drug in China, 2022 |
| title_short | Analysis of the progress of clinical trials for ophthalmic drug in China, 2022 |
| title_sort | analysis of the progress of clinical trials for ophthalmic drug in china 2022 |
| topic | drug clinical trials ophthalmology clinical trials drug china age-related macular degeneration myopia |
| url | http://ies.ijo.cn/cn_publish/2023/7/202307032.pdf |
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