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Analysis of critical factors in evaluation system for multicenter clinical trials sites
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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
Chinese Journal of Clinical Pharmacology | 2026, 42(10) : 1474 - 1478
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Chinese Journal of Clinical Pharmacology | 2026, 42(10): 1474-1478
• Regulatory Science Column •
Analysis of critical factors in evaluation system for multicenter clinical trials sites
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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
Published: 2026-05-28 doi: 10.13699/j.cnki.1001-6821.2026.10.020
Outline
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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
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
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Article Info
doi: 10.13699/j.cnki.1001-6821.2026.10.020
  • Receive Date：2026-05-04
  • Online Date：2026-08-06
  • Published：2026-05-28
Article Data
Affiliations
History
  • Received：2026-05-04
Funding
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
References
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