Article(id=1292135446004392740, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.10.020, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1777824000000, receivedDateStr=2026-05-04, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785998697043, onlineDateStr=2026-08-06, pubDate=1779897600000, pubDateStr=2026-05-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785998697043, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785998697043, creator=13701087609, updateTime=1785998697043, updator=13701087609, issue=Issue{id=1292135425250976333, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='10', pageStart='1351', pageEnd='1500', issueExtLink='null', onlineDate='null', pubDate='1779897600000', pubDateStr='2026-05-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785998692095, creator='13701087609', updateTime=1786014373634, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201198489202995, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201198489202996, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292135425250976333, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1474, endPage=1478, ext={EN=ArticleExt(id=1292135446176359205, articleId=1292135446004392740, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Analysis of critical factors in evaluation system for multicenter clinical trials sites, columnId=1292126496848638045, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Regulatory Science Column, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the key elements in the evaluation and selection of sites for multicenter clinical trials, providing references for standardizing clinical trial site selection practices.

Methods

By integrating the practical experience of multiple sponsors, contract research organizations (CROs), and research sites, a standardized framework for site evaluation and selection was constructed.

Results

A three-phase standardized process was proposed, encompassing pre-assessment preparation, formal evaluation, and outcome assessment. This study systematically categorized common and specific evaluation criteria, including 5 core dimensions and 17 key indicators covering site and personnel qualifications, hardware conditions, patient resources and quality systems, management processes, and special considerations.

Conclusion

This study constructed a comprehensive site evaluation system encompassing standardized procedures, structured dimensions, and core indicators. It achieves a transformation in evaluation practices from an experience-driven approach to a framework-guided methodology, providing an operable tool for the scientific selection of sites in multicenter clinical trials.

, authors=Hong FANG1, Shuo-peng JIA1, Yi-ru HOU1, Fu-nan LIU2, Li-ping ZHOU2, Xiu-fang CHU3, Kun-wei ZHANG4, Lu LIU5, Ke REN6, Jin-hua TAO7, Xing-fang FAN8, Shao-lei ZHANG9, Xiao-kang ZHANG10, Lei GAO11, Gloria LIU12, Chen SUN13, An-bang TANG14, Ning LI1, Yu TANG1, authorsList=Hong FANG, Shuo-peng JIA, Yi-ru HOU, Fu-nan LIU, Li-ping ZHOU, Xiu-fang CHU, Kun-wei ZHANG, Lu LIU, Ke REN, Jin-hua TAO, Xing-fang FAN, Shao-lei ZHANG, Xiao-kang ZHANG, Lei GAO, Gloria LIU, Chen SUN, An-bang TANG, Ning LI, Yu TANG, authorCompany=null, correspAuthors=Yu TANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292135446553846566, articleId=1292135446004392740, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=多中心临床试验研究中心评估体系的构建与要点分析, columnId=1292126497112879199, journalTitle=中国临床药理学杂志, columnName=药物监管科学专栏, runingTitle=null, highlight=null, articleAbstract=
目的

探讨多中心临床试验研究中心评估与筛选的关键要素,为规范临床试验选点工作提供参考。

方法

通过整合多家申办方、合同研究组织和研究中心的实践经验,构建研究中心筛选调研的规范化框架。

结果

本研究提出了包含调研前准备、正式调研和结果评估三阶段的标准化流程,系统梳理了共性和特性内容的调研要点,包括研究中心和人员资质、硬件条件、患者资源和质量体系、管理流程、特殊关注的5个评估维度和17项核心指标。

结论

本研究构建了一套包含标准化流程、结构化维度和核心指标的研究中心评估体系,实现了评估工作从经验主导向框架指引的转变,为多中心临床试验对研究中心的科学筛选提供了可操作的工具。

, authors=房虹1, 贾硕鹏1, 侯怡如1, 刘福囝2, 周立平2, 褚秀芳3, 张琨玮4, 柳璐5, 任科6, 陶金华7, 樊兴芳8, 张少垒9, 张小康10, 高磊11, Gloria LIU12, 孙辰13, 汤安邦14, 李宁1, 唐玉1, authorsList=房虹, 贾硕鹏, 侯怡如, 刘福囝, 周立平, 褚秀芳, 张琨玮, 柳璐, 任科, 陶金华, 樊兴芳, 张少垒, 张小康, 高磊, Gloria LIU, 孙辰, 汤安邦, 李宁, 唐玉, authorCompany=null, correspAuthors=唐玉, authorNote=

房虹(1982-),女,主管药师,主要从事肿瘤临床相关研究

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唐玉,副主任药师 MP: 13521662807 E-mail:
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多中心临床试验研究中心评估体系的构建与要点分析
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房虹 1 , 贾硕鹏 1 , 侯怡如 1 , 刘福囝 2 , 周立平 2 , 褚秀芳 3 , 张琨玮 4 , 柳璐 5 , 任科 6 , 陶金华 7 , 樊兴芳 8 , 张少垒 9 , 张小康 10 , 高磊 11 , Gloria LIU 12 , 孙辰 13 , 汤安邦 14 , 李宁 1 , 唐玉 1
中国临床药理学杂志 | 药物监管科学专栏 2026,42(10): 1474-1478
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中国临床药理学杂志 |药物监管科学专栏 2026 , 42 (10) : 1474 -1478
多中心临床试验研究中心评估体系的构建与要点分析
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房虹1, 贾硕鹏1, 侯怡如1, 刘福囝2, 周立平2, 褚秀芳3, 张琨玮4, 柳璐5, 任科6, 陶金华7, 樊兴芳8, 张少垒9, 张小康10, 高磊11, Gloria LIU12, 孙辰13, 汤安邦14, 李宁1, 唐玉1
作者信息
  • 1.国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京 100021
  • 2.国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院辽宁医院,沈阳 110000
  • 3.精鼎医药研究开发(上海)有限公司,上海 200131
  • 4.艾昆纬医药科技(上海)有限公司,上海 200040
  • 5.默沙东(中国)投资有限公司,上海 200040
  • 6.上海药明津石医药科技有限公司,上海 200131
  • 7.罗氏(中国)投资有限公司,上海 200131
  • 8.拜耳(中国)有限公司,北京 100020
  • 9.阿斯利康全球研发(中国)有限公司,上海 201203
  • 10.强生(中国)投资有限公司,上海 200040
  • 11.复星医药科技开发有限公司,上海 200001
  • 12.赛纽仕医药咨询(上海)有限公司,上海 200030
  • 13.杭州泰格医药科技股份有限公司,杭州 310052
  • 14.药研社(江苏)医药科技有限公司,苏州 215123
通讯作者:
唐玉,副主任药师 MP: 13521662807 E-mail:
作者简介:

房虹(1982-),女,主管药师,主要从事肿瘤临床相关研究

Analysis of critical factors in evaluation system for multicenter clinical trials sites
Hong FANG1, Shuo-peng JIA1, Yi-ru HOU1, Fu-nan LIU2, Li-ping ZHOU2, Xiu-fang CHU3, Kun-wei ZHANG4, Lu LIU5, Ke REN6, Jin-hua TAO7, Xing-fang FAN8, Shao-lei ZHANG9, Xiao-kang ZHANG10, Lei GAO11, Gloria LIU12, Chen SUN13, An-bang TANG14, Ning LI1, Yu TANG1
Affiliations
  • 1.Department of Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China
  • 2.National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Liaoning Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenyang 110000, Liaoning Province, China
  • 3.Parexel International (Shanghai) Co., Ltd., Shanghai 200131, China
  • 4.IQVIA (Shanghai) Medical Technology Co., Ltd., Shanghai 200040, China
  • 5.MSD (China) Holding Co., Ltd., Shanghai 200040, China
  • 6.Shanghai WuXi Jinshi Medical Technology Co., Ltd., Shanghai 200131, China
  • 7.Roche (China) Holding Co., Ltd., Shanghai 200131, China
  • 8.Bayer (China) Co., Ltd., Beijing 100020, China
  • 9.AstraZeneca Global R&D (China) Co., Ltd., Shanghai 201203, China
  • 10.Johnson & Johnson (China) Investment Co., Ltd., Shanghai 200040, China
  • 11.Fosun Pharma Technology Development Co., Ltd., Shanghai 200001, China
  • 12.Syneos Health Consulting (Shanghai) Co., Ltd., Shanghai 200030, China
  • 13.Hangzhou Tigermed Consulting Co., Ltd., Hangzhou 310052, Zhejiang Province, China
  • 14.Yaoyanshe (Jiangsu) Medical Technology Co., Ltd., Suzhou 215123, Jiangsu Province, China
出版时间: 2026-05-28 doi: 10.13699/j.cnki.1001-6821.2026.10.020
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目的

探讨多中心临床试验研究中心评估与筛选的关键要素,为规范临床试验选点工作提供参考。

方法

通过整合多家申办方、合同研究组织和研究中心的实践经验,构建研究中心筛选调研的规范化框架。

结果

本研究提出了包含调研前准备、正式调研和结果评估三阶段的标准化流程,系统梳理了共性和特性内容的调研要点,包括研究中心和人员资质、硬件条件、患者资源和质量体系、管理流程、特殊关注的5个评估维度和17项核心指标。

结论

本研究构建了一套包含标准化流程、结构化维度和核心指标的研究中心评估体系,实现了评估工作从经验主导向框架指引的转变,为多中心临床试验对研究中心的科学筛选提供了可操作的工具。

多中心临床试验  /  研究中心筛选  /  评估要点  /  调研流程
Objective

To explore the key elements in the evaluation and selection of sites for multicenter clinical trials, providing references for standardizing clinical trial site selection practices.

Methods

By integrating the practical experience of multiple sponsors, contract research organizations (CROs), and research sites, a standardized framework for site evaluation and selection was constructed.

Results

A three-phase standardized process was proposed, encompassing pre-assessment preparation, formal evaluation, and outcome assessment. This study systematically categorized common and specific evaluation criteria, including 5 core dimensions and 17 key indicators covering site and personnel qualifications, hardware conditions, patient resources and quality systems, management processes, and special considerations.

Conclusion

This study constructed a comprehensive site evaluation system encompassing standardized procedures, structured dimensions, and core indicators. It achieves a transformation in evaluation practices from an experience-driven approach to a framework-guided methodology, providing an operable tool for the scientific selection of sites in multicenter clinical trials.

multicenter clinical trials  /  site selection  /  evaluation criteria  /  assessment process
房虹, 贾硕鹏, 侯怡如, 刘福囝, 周立平, 褚秀芳, 张琨玮, 柳璐, 任科, 陶金华, 樊兴芳, 张少垒, 张小康, 高磊, Gloria LIU, 孙辰, 汤安邦, 李宁, 唐玉. 多中心临床试验研究中心评估体系的构建与要点分析. 中国临床药理学杂志, 2026 , 42 (10) : 1474 -1478 . DOI: 10.13699/j.cnki.1001-6821.2026.10.020
Hong FANG, Shuo-peng JIA, Yi-ru HOU, Fu-nan LIU, Li-ping ZHOU, Xiu-fang CHU, Kun-wei ZHANG, Lu LIU, Ke REN, Jin-hua TAO, Xing-fang FAN, Shao-lei ZHANG, Xiao-kang ZHANG, Lei GAO, Gloria LIU, Chen SUN, An-bang TANG, Ning LI, Yu TANG. Analysis of critical factors in evaluation system for multicenter clinical trials sites[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (10) : 1474 -1478 . DOI: 10.13699/j.cnki.1001-6821.2026.10.020
  • 国家重点研发计划资助项目(2022YFC2409504)
  • 中国医学科学院肿瘤医院临床学科建设项目(880102022517)
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doi: 10.13699/j.cnki.1001-6821.2026.10.020
  • 接收时间:2026-05-04
  • 首发时间:2026-08-06
  • 出版时间:2026-05-28
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出版历史
  • 收稿日期:2026-05-04
基金
国家重点研发计划资助项目(2022YFC2409504)
中国医学科学院肿瘤医院临床学科建设项目(880102022517)
作者信息
    1.国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京 100021
    2.国家癌症中心 国家肿瘤临床医学研究中心 中国医学科学院北京协和医学院肿瘤医院辽宁医院,沈阳 110000
    3.精鼎医药研究开发(上海)有限公司,上海 200131
    4.艾昆纬医药科技(上海)有限公司,上海 200040
    5.默沙东(中国)投资有限公司,上海 200040
    6.上海药明津石医药科技有限公司,上海 200131
    7.罗氏(中国)投资有限公司,上海 200131
    8.拜耳(中国)有限公司,北京 100020
    9.阿斯利康全球研发(中国)有限公司,上海 201203
    10.强生(中国)投资有限公司,上海 200040
    11.复星医药科技开发有限公司,上海 200001
    12.赛纽仕医药咨询(上海)有限公司,上海 200030
    13.杭州泰格医药科技股份有限公司,杭州 310052
    14.药研社(江苏)医药科技有限公司,苏州 215123

通讯作者:

唐玉,副主任药师 MP: 13521662807 E-mail:
参考文献
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2种不同金属材料的力学参数

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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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