Analysis of the current status of clinical trial institutions for neuropsychiatric medical devices in China
10.3969/j.issn.1673-9701.2024.33.009
- VernacularTitle:中国神经精神科医疗器械临床试验机构现状分析
- Author:
Xin LI
1
;
Yanfei YE
;
Shijie SONG
;
Yuwen WANG
Author Information
1. 浙江大学医学院附属精神卫生中心杭州市第七人民医院临床试验机构办公室,浙江 杭州 310007
- Keywords:
Psychiatry;
Neurology;
Neurosurgery;
Medical device clinical trial institution;
Organization and management
- From:
China Modern Doctor
2024;62(33):43-46,150
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the current status of medical device of clinical trial institutions specializing in psychiatry,neurology,and neurosurgery in China after the implementation of the registration system.Methods By searching the medical device clinical trial institution registration management information platform,statistical analysis was conducted on the number,category and grades,geographical distribution,number of principal investigators and aptitude,and cross-distribution of medical device clinical trial institutions specializing in psychiatry,neurology,and neurosurgery.Results Since the implementation of the registration system,up to August 6,2024,111 psychiatric,588 neurological,and 418 neurosurgical institutions that had registered distributed across 27,30,and 29 provincial-level administrative regions in China,respectively.Among these institutions,73.0％,66.5％and 76.6％were tertiary grade A hospitals,respectively.The number of registered principal investigators were 524,1635 and 1128 persons,respectively.The registered institutions were mainly distributed in relatively developed urban clusters in the Yangtze River Delta,Pearl River Delta,and Beijing-Tianjin-Hebei region.Conclusion Tertiary grade A hospitals dominate medical device clinical trial institutions specializing in psychiatry,neurology and neurosurgery in China.The implementation of the registration system has promoted the release of medical resources in the neuropsychiatric field.However,issues such as significant regional differences in the number of clinical trial institutions and the concentration of researcher resources exist.
