机构:[1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing, China.首都医科大学附属北京同仁医院研究所眼科研究所
Purpose: We systematically retrospected and analyzed the general characteristics of ophthalmic drug clinical trials (CTs) registered in China from January 2014 to December 2021. Methods: Data were retrieved from the Drug Trial Registration and Information Publication Platform and then standardized and statistically classified using bibliometric analysis. Results: We identified 201 drug CTs for eye diseases, including 24 international multicenter trials. The number of drug CTs for eye diseases has considerably increased since 2017 in parallel with new policies to encourage innovation in drugs and medical devices in China. The drug types consist of biologicals (48.26%), chemicals (45.77%), and traditional Chinese medicine/natural medicines (5.97%). The main indications were age-related macular degeneration (AMD; n = 47, 23.38%), macular edema (n = 32, 15.92%), and diabetic retinopathy (n = 19, 9.45%). The trials included those in phase I (n = 67, 33.33%), phase II (n = 33, 16.42%), and phase III (n = 72, 35.82%). The phase I trials comprised 24 innovative drug treatments for AMD and 6 novel drug treatments for neuromyelitis optica spectrum disorders, with 39 biologicals and 27 chemicals. The trials mostly followed a randomized (84.08%) or masked (67.16%) design, with 90.37% of the latter being double-masked trials. Conclusion: Research and development of ophthalmic drugs have substantially increased in recent years and are influenced by regulatory policies. Among these drugs, biologicals for AMD are the most prevalent, followed by biologicals for macular edema. Randomized double-masked research designs are often used and represent high-quality evidence.
基金:
This study was supported by the Science and Technology
Project of Beijing Science and Technology Commission
(No. Z201100005520034).
第一作者机构:[1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
通讯作者:
通讯机构:[1]Beijing Institute of Ophthalmology, Beijing Tongren Eye Center, Beijing Ophthalmology and Visual Sciences Key Laboratory, Beijing Tongren Hospital, Capital Medical University, Beijing, China.[*1]Beijing Institute of Ophthalmology,Beijing Tongren Eye Center,Beijing Ophthalmology and Visual Sciences,Key Laboratory,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China
推荐引用方式(GB/T 7714):
Hu Jianping,Ma Qian,Xin Chen,et al.Analysis of Drug Clinical Trials for Eye Diseases in China[J].JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS.2022,38(9):645-653.doi:10.1089/jop.2021.0126.
APA:
Hu Jianping,Ma Qian,Xin Chen&Jiao Yonghong.(2022).Analysis of Drug Clinical Trials for Eye Diseases in China.JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS,38,(9)
MLA:
Hu Jianping,et al."Analysis of Drug Clinical Trials for Eye Diseases in China".JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS 38..9(2022):645-653