Keywords
Drug clinical trial institutions
Research personnel
Registration system
Submitted : 2024-11-09
Accepted : 2024-11-24
Published : 2024-12-09
Abstract
Objective: To analyze the status of ophthalmology drug clinical trial institutions in China following the implementation of the registration system and provide a reference for their development. Methods: An analysis was conducted using data from the Drug Clinical Trial Institution Registration Management Information Platform and the Drug Clinical Trial Registration and Information Publicity Platform of the National Medical Products Administration. The search period was up to April 19, 2024. Results: As of April 19, 2024, 314 ophthalmology-specific institutions were registered nationwide, comprising 274 comprehensive medical institutions and 40 specialized ophthalmology institutions, representing a 245% increase compared to the qualification certification phase. There were 965 major researchers in ophthalmology, accounting for 6.3% of the total number of researchers across all registered ophthalmology institutions. These institutions were predominantly located in economically developed areas such as Guangdong, Zhejiang, and Jiangsu Provinces, with the top five provinces and cities comprising 39.8% of the total registered institutions. Beijing had the highest number of major researchers (126), with their distribution positively correlated with the geographic spread of registered institutions. Furthermore, as of April 19, 2024, there were 216 clinical drugs related to eye diseases, with the top three provinces conducting 77.8% of national clinical trial projects. The number of institutions was directly proportional to the volume of clinical trials conducted. Conclusion: The implementation of the registration system has facilitated the release of ophthalmic medical resources. However, regional disparities remain in the number of ophthalmology-specific institutions, the availability of major investigators, and the distribution of clinical trial projects.
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