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Article(id=1239201877594788400, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239201870791627164, articleNumber=null, orderNo=null, doi=10.14109/j.cnki.xyylc.2024.03.05, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1681660800000, receivedDateStr=2023-04-17, revisedDate=null, revisedDateStr=null, acceptedDate=1702569600000, acceptedDateStr=2023-12-15, onlineDate=1773378350876, onlineDateStr=2026-03-13, pubDate=1711296000000, pubDateStr=2024-03-25, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773378350876, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773378350876, creator=13701087609, updateTime=1773378350876, updator=13701087609, issue=Issue{id=1239201870791627164, tenantId=1146029695717560320, journalId=1205117082300743687, year='2024', volume='43', issue='3', pageStart='161', pageEnd='240', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773378349254, creator=13701087609, updateTime=1773378470498, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239202379392938830, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239201870791627164, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239202379397133135, tenantId=1146029695717560320, journalId=1205117082300743687, issueId=1239201870791627164, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=188, endPage=191, ext={EN=ArticleExt(id=1239201877800309302, articleId=1239201877594788400, tenantId=1146029695717560320, journalId=1205117082300743687, language=EN, title=Analysis of current situation of clinical trial institutions of psychiatric specialty in China, columnId=1207314215644270693, journalTitle=Chinese Journal of New Drugs and Clinical Remedies, columnName=Policy and Management, runingTitle=null, highlight=null, articleAbstract=
AIM

To know the current status of clinical trial institutions on psychiatric specialty in China since the drug clinical trial institution registration came into force.

METHODS

By searching for the psychiatric professional institutions and investigators registrated in the drug clinical trial institution filing management information platform and clinical trial data of psychiatric drugs published on the official website of the National Medical Products Administration, the regional distribution of psychiatric drug clinical trial institutions, principal investigators, and the number and types of clinical trials were statistically analyzed.

RESULTS

After the implementation of the filing system, as of March 10, 2023, there were a total of 104 psychiatric professional filing institutions in China, distributed in 26 provincial-level administrative regions across the country, with a total of 927 registered researchers. Except for one psychiatric hospital, which was a second level hospital, all other hospitals were third level hospitals. A total of 91 institutions had undertaken 122 clinical trials, and among the top ten institutions in terms of project quantity, there were 9 psychiatric hospitals.

CONCLUSION

The psychiatric departments of the tertiary comprehensive hospitals are the main force for clinical trial institutions registration, but in terms of undertaking clinical trials, specialized psychiatric hospitals have the main advantage, and there are problems such as uneven distribution of registered institutions regions, registered investigators, and the number of clinical trials undertaken.

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目的

了解药物临床试验机构备案制实施后我国精神科专业临床试验机构的现状。

方法

通过检索药物临床试验机构备案管理信息平台备案的精神科专业备案机构和研究者，以及国家药品监督管理局官网公示的精神科药物临床试验数据，对精神科药物临床试验机构地域分布、主要研究者、临床试验数量和类型等相关情况进行统计分析。

结果

自备案制实施后，截至2023年3月10日，我国精神科专业备案机构共有104家，分布于全国26个省级行政区，备案研究者总数为927人次；除了1家精神专科医院为二级医院外，其余均为三级医院；共有91家机构承接了122项临床试验，承接项目数量排前十的机构中9家为精神专科医院。

结论

我国精神科专业临床试验机构以三级综合医院精神科为主力，但在临床试验承接方面，精神专科医院占据主要优势，且存在备案机构区域、备案研究者及承担临床试验数量分布不均衡的问题。

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沈一峰，E-mail:
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魏宇梅，女，助理研究员，硕士，主要从事临床试验项目管理工作，E-mail:

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机构承担临床试验总数作为组长单位承担临床试验数量是否精神专科医院
首都医科大学附属北京安定医院4631是
上海市精神卫生中心3722是
北京回龙观医院293是
武汉市精神卫生中心287是
西安市精神卫生中心240是
北京大学第六医院238是
广州医科大学附属脑科医院231是
河北医科大学第一医院232否
天津市安定医院230是
湖南省脑科医院200是
), ArticleFig(id=1239201883320013606, tenantId=1146029695717560320, journalId=1205117082300743687, articleId=1239201877594788400, language=CN, label=表1, caption=

承担临床试验数量排名前十的机构

, figureFileSmall=null, figureFileBig=null, tableContent=
机构承担临床试验总数作为组长单位承担临床试验数量是否精神专科医院
首都医科大学附属北京安定医院4631是
上海市精神卫生中心3722是
北京回龙观医院293是
武汉市精神卫生中心287是
西安市精神卫生中心240是
北京大学第六医院238是
广州医科大学附属脑科医院231是
河北医科大学第一医院232否
天津市安定医院230是
湖南省脑科医院200是
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我国精神科专业药物临床试验机构现状分析
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魏宇梅 1 , 方思乔 2 , 黄志伟 1 , 郑园园 3 , 沈一峰 1
中国新药与临床杂志 | 政策与管理 2024,43(3): 188-191
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中国新药与临床杂志 | 政策与管理 2024, 43(3): 188-191
我国精神科专业药物临床试验机构现状分析
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魏宇梅1 , 方思乔2, 黄志伟1, 郑园园3, 沈一峰1
作者信息
  • 1.上海交通大学医学院附属精神卫生中心，上海　200032
  • 2.北京博润阳光科技有限公司　医学科学中心，北京　100011
  • 3.吉林省神经精神病医院，吉林　四平　136000

    • 魏宇梅，女，助理研究员，硕士，主要从事临床试验项目管理工作，E-mail:

通讯作者:

沈一峰，E-mail:
Analysis of current situation of clinical trial institutions of psychiatric specialty in China
Yu-mei WEI1 , Si-qiao FANG2, Zhi-wei HUANG1, Yuan-yuan ZHENG3, Yi-feng SHEN1
Affiliations
  • 1.Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, SHANGHAI 200032, China
  • 2.Medical Science Center, Beijing B&R Pharma Co., Ltd., BEIJING 100011, China
  • 3.Jilin Neuropsychiatric Hospital, Siping JILIN 136000, China
出版时间: 2024-03-25 doi: 10.14109/j.cnki.xyylc.2024.03.05
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摘要
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目的

了解药物临床试验机构备案制实施后我国精神科专业临床试验机构的现状。

方法

通过检索药物临床试验机构备案管理信息平台备案的精神科专业备案机构和研究者，以及国家药品监督管理局官网公示的精神科药物临床试验数据，对精神科药物临床试验机构地域分布、主要研究者、临床试验数量和类型等相关情况进行统计分析。

结果

自备案制实施后，截至2023年3月10日，我国精神科专业备案机构共有104家，分布于全国26个省级行政区，备案研究者总数为927人次；除了1家精神专科医院为二级医院外，其余均为三级医院；共有91家机构承接了122项临床试验，承接项目数量排前十的机构中9家为精神专科医院。

结论

我国精神科专业临床试验机构以三级综合医院精神科为主力，但在临床试验承接方面，精神专科医院占据主要优势，且存在备案机构区域、备案研究者及承担临床试验数量分布不均衡的问题。

精神病科，医院  /  临床试验  /  药物临床试验机构  /  组织和管理
AIM

To know the current status of clinical trial institutions on psychiatric specialty in China since the drug clinical trial institution registration came into force.

METHODS

By searching for the psychiatric professional institutions and investigators registrated in the drug clinical trial institution filing management information platform and clinical trial data of psychiatric drugs published on the official website of the National Medical Products Administration, the regional distribution of psychiatric drug clinical trial institutions, principal investigators, and the number and types of clinical trials were statistically analyzed.

RESULTS

After the implementation of the filing system, as of March 10, 2023, there were a total of 104 psychiatric professional filing institutions in China, distributed in 26 provincial-level administrative regions across the country, with a total of 927 registered researchers. Except for one psychiatric hospital, which was a second level hospital, all other hospitals were third level hospitals. A total of 91 institutions had undertaken 122 clinical trials, and among the top ten institutions in terms of project quantity, there were 9 psychiatric hospitals.

CONCLUSION

The psychiatric departments of the tertiary comprehensive hospitals are the main force for clinical trial institutions registration, but in terms of undertaking clinical trials, specialized psychiatric hospitals have the main advantage, and there are problems such as uneven distribution of registered institutions regions, registered investigators, and the number of clinical trials undertaken.

psychiatric department, hospital  /  clinical trial  /  drug clinical trial institutions  /  organization and administration
魏宇梅, 方思乔, 黄志伟, 郑园园, 沈一峰. 我国精神科专业药物临床试验机构现状分析. 中国新药与临床杂志, 2024 , 43 (3) : 188 -191 . DOI: 10.14109/j.cnki.xyylc.2024.03.05
Yu-mei WEI, Si-qiao FANG, Zhi-wei HUANG, Yuan-yuan ZHENG, Yi-feng SHEN. Analysis of current situation of clinical trial institutions of psychiatric specialty in China[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (3) : 188 -191 . DOI: 10.14109/j.cnki.xyylc.2024.03.05
正文
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2017年10月，中共中央办公厅、国务院办公厅发布的《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》提出药物临床试验机构（简称“机构”）资格认定实行备案管理[1]。2019年11月29日，国家药品监督管理局会同国家卫生健康委员会发布《药物临床试验机构管理规定》，自2019年12月1日起，相关机构和单位应按照要求在“药物临床试验机构备案管理信息系统”进行备案，2019年12月1日至2020年11月30日为“备案过渡期”，自2020年12月1起，申办者应选取已备案机构开展临床试验[2]。这对我国药物临床试验领域的整体发展影响深远。为促进行业有效利用备案机构资源，深入了解完成备案机构承接药物临床试验的现状，本研究通过检索机构备案管理信息平台，并结合药物临床试验登记与信息公示平台登记的精神科临床试验数据，分析我国精神科专业临床试验现状，以了解备案制实施后我国精神科专业临床试验机构的具体状况，为我国精神科药物临床试验合理布局、均衡发展提供参考。
材料与方法
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资料来源
所有数据资料来源于“药物临床试验机构备案管理信息平台”（https://beian.cfdi.org.cn/CTMDS/apps/pub/drugPublic.jsp）和药品审评中心“药物临床试验登记与信息公示平台”（www.chinadrugtrials.org.cn）。数据检索时间为2020年1月1日至2023年3月10日。
数据收集和研究方法
检索备案管理信息系统平台上精神科专业备案机构和研究者，对机构数量及类型、地域分布、承接临床试验项目数量、备案专业及主要研究者进行分析，并对备案机构或研究者在药物临床试验登记与信息公示平台的临床试验项目情况进行统计分析。所有检索数据导出至Excel软件，由专业统计人员进行整理、审核和分析。
结果
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精神科专业备案机构数量
根据机构备案管理信息平台显示，截至2023年3月10日，精神科专业（包括精神病、精神卫生、药物依赖、精神康复、临床心理等）备案的机构共有104家。《药物临床试验机构管理规定》实施的当年，即2019年，备案机构有9家，2020年备案71家，2021年9家，2022年12家，2023年截至3月10日备案3家。在机构级别上，除了1家精神专科医院为二级医院外，其余均为三级医院。在机构类别上，以综合医院精神科为主，共59家，占比56.7%；其次为精神专科医院，共39家，占比37.5%；其余为中医院，共6家，占5.8%。
备案机构区域分布
备案的104家机构分布于全国26个省级行政区，根据各省级行政区备案的机构数量排序，精神科专业备案机构数量最多的前三位省级行政区依次为浙江省（19家）、广东省（9家）和四川省（8家）。见图1。
备案研究者整体概况
目前精神科专业备案研究者总数（含Ⅰ期药物临床试验研究者）为927人次，数量最多的前五位省级行政区依次为浙江省（128人次，占比13.8%）、广东省（103人次，占比11.1%）、北京市（96人次，占比10.4%）、陕西省（78人次，占比8.4%）和江苏省（67人次，占比7.2%）。见图2。不同类别机构中，三级综合医院备案研究者最多，为480人次，占比51.8%；精神专科医院备案433人次，占比46.7%；中医院备案14人次，占比1.5%。
精神专科医院研究者备案情况
备案的39家精神专科医院中，备案研究者人次排名前十的机构为西安市精神卫生中心（68人次）、上海市精神卫生中心（29人次）、首都医科大学附属北京安定医院（29人次）、北京大学第六医院（26人次）、北京回龙观医院（23人次）、河南省精神病医院（22人次）、湖南省脑科医院（19人次）、深圳市康宁医院（17人次）、湖州市第三人民医院（16人次）、广州医科大学附属脑科医院（14人次）。有13家精神专科医院有Ⅰ期药物临床试验研究者备案，总人次为104人，人数较多的是西安市精神卫生中心（36人）、上海市精神卫生中心（11人）、首都医科大学附属北京安定医院（10人）、北京回龙观医院（8人）、湖南省脑科医院（湖南省第二人民医院，8人）等。
备案机构承接临床试验情况
在精神科专业备案的104家机构中，共有91家机构承接了122项临床试验。2020年有21项精神科项目，2021年和2022年均为46项，2023年截至3月10日有9项。承接项目数量排前十的机构中9家为精神专科医院，见表1。另外，总共有20家机构作为组长单位承接过项目，其中以首都医科大学附属北京安定医院和上海市精神卫生中心作为组长单位承接项目最多，近3年分别承接了31项和22项，远超其余18家机构。
精神科专业备案机构承接的122项临床试验中，有15项国际多中心试验，包括8项阿尔茨海默病、4项精神分裂症、2项强迫症和1项抑郁症。在药物类别上，以化药为主（105项），其次为中药/天然药（12项），其余为生物制品（5项）。在适应证方面，涉及精神分裂症（44项）、抑郁症（33项）、阿尔茨海默病（19项）、失眠症（9项）、焦虑症（5项）、注意缺陷与多动障碍（4项）、强迫症（2项）、双相障碍（1项）、酒精使用障碍（1项）、缓解精神疲劳（1项）、抽动症（1项）、毒品成瘾（1项）、阿片类物质成瘾（1项）共13个适应证。在试验分期上，以生物等效性试验居多（37项），其次为Ⅰ期临床试验（30项）、Ⅲ期临床试验（29项）、Ⅱ期临床试验（19项）、其他（4项）和Ⅳ期临床试验（3项）。
讨论
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截至2023年3月10日，备案管理信息系统平台上共有104家机构完成精神科专业（包括精神病、精神卫生、药物依赖、精神康复、临床心理等）备案，其中三级综合医院为备案主力，占56.7%，精神专科医院占37.5%。但在临床试验承接方面，精神专科医院占据主要优势，在承接项目数量排前十的机构中有9家为精神专科医院。
从区域上看，各省级行政区备案机构数量差异大，尚有部分省份无精神科专业机构备案。与我国机构整体备案现状类似[3]，各省级行政区的精神科备案机构数量与承接临床试验项目数量并非呈正相关，北京、上海等一线城市凭借优质的医疗资源承担着较多的临床试验。精神科备案研究者数量（927人次）远低于其他专业如神经内科的研究者数量（1 307人次）[4]。由于神经内科和精神科专业的特殊性和交叉性，在目前临床试验实施的实践中，部分医院未独立设置精神科，部分精神科临床试验由神经内科及其研究者承担，因此这部分数据未计入此次统计中。
临床试验药物研发需求与患病率密切相关，根据中国精神卫生调查（CMHS）数据显示，中国六大类精神障碍疾病为心境障碍、焦虑障碍、酒精/药物使用障碍、精神分裂症及相关精神病性障碍、进食障碍、冲动控制障碍[5]，本研究显示，精神分裂症、抑郁症、阿尔茨海默病、失眠症、焦虑症等具有较高的药物研发活跃度，合计占据临床试验适应证的90%。同时，截止至2023年3月共有13家精神专科医院完成Ⅰ期药物临床试验研究者备案，但从试验分期上分析，以生物等效性试验居多，表明我国精神科药物研发创新性方面还亟待提升。
另外，尽管机构备案制的实施有助于释放临床资源，满足药物临床试验需求[6]，但目前尚有部分已备案精神科药物机构未承担过精神科专业临床试验，表明备案制的实施虽然在一定程度上增加了药物临床试验资源供给，但在短时间内精神科药物临床试验仍然相对比较集中，均衡化还将有一段路要走。
2022年12月中国医院协会联合目前国内具备较高精神疾病诊疗和科研水平的医疗卫生机构，本着自愿、平等、合作、共享的原则，共同成立“精神药物临床试验协作网”，目前已有55家成员单位。通过搭建全国精神药物机构学术交流平台，开展学术研讨、专业培训、专科调研、机构走访等活动，有助于持续提升精神药物临床试验质量与临床研究管理水平，进一步提高临床研究的质量和效率，推动我国精神药物的创新研发。行业多方的协同努力必然会推动精神药物机构整体能力水平的提升以及各机构间的均衡发展。
基金
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  • 上海申康医院发展中心医企融合创新支撑技能培训专项(SHDC2022CRS032)
  • 上海转化医学协同创新中心课题(TM202116PT)
  • 上海市精神心理疾病临床医学研究中心课题(19MC1911100)
文献
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参考文献 引证文献
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2024年第43卷第3期
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doi: 10.14109/j.cnki.xyylc.2024.03.05
  • 接收时间：2023-04-17
  • 首发时间：2026-03-13
  • 出版时间：2024-03-25
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  • 收稿日期：2023-04-17
  • 录用日期：2023-12-15
基金
上海申康医院发展中心医企融合创新支撑技能培训专项(SHDC2022CRS032)
上海转化医学协同创新中心课题(TM202116PT)
上海市精神心理疾病临床医学研究中心课题(19MC1911100)
作者信息
    1.上海交通大学医学院附属精神卫生中心，上海　200032
    2.北京博润阳光科技有限公司　医学科学中心，北京　100011
    3.吉林省神经精神病医院，吉林　四平　136000

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沈一峰，E-mail:
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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