中国神经精神科医疗器械临床试验机构现状分析

Analysis of the current status of clinical trial institutions for neuropsychiatric medical devices in China

目的探讨备案制实施后中国精神科、神经内科和神经外科专业医疗器械临床试验机构的现状。方法通过检索医疗器械临床试验机构备案管理信息平台,分别对精神科、神经内科和神经外科专业医疗器械临床试验机构的数量、类别和等级、地域分布、主要研究者数量和资质、各专业交叉分布等相关情况进行统计分析。结果自备案制实施以来,截至2024年8月6日,中国精神科已备案的111家、神经内科已备案的588家和神经外科已备案的418家机构分别分布于全国的27、30和29个省级行政区,三级甲等医院所占比例分别为73.0%、66.5%和76.6%,已备案的主要研究者数量分别为524、1635、1128人次,备案机构主要分布于长三角、珠三角和京津冀相对发达的城市集群。结论中国精神科、神经内科和神经外科专业医疗器械临床试验机构以三级甲等医院为主,备案制的实施可促使神经精神领域医疗资源的释放,但存在临床试验机构数量地区差异大、研究者资源集中等问题。

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.