上海交通大学医学院临床试验研究现状分析

doi:10.3969/j.issn.1674-8115.2022.08.001

上海交通大学学报（医学版） ›› 2022, Vol. 42 ›› Issue (8): 971-979.doi: 10.3969/j.issn.1674-8115.2022.08.001

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上海交通大学医学院临床试验研究现状分析

彭树涛¹(), 仇晓春²()

^1.上海交通大学医学院医学教育研究所，上海 200025
^2.上海交通大学医学院图书馆，上海 200025

收稿日期:2022-06-16 接受日期:2022-08-10 出版日期:2022-08-28 发布日期:2022-10-08
通讯作者: 仇晓春 E-mail:pengshutao@shsmu.edu.cn;tsg2@shsmu.edu.cn
作者简介:彭树涛（1979—），男，副研究员，博士；电子信箱： pengshutao@shsmu.edu.cn。
基金资助:
上海市社科规划一般课题(2020BKS003);上海高校智库内涵建设计划(20ZKNH040);上海交通大学智库引导性研究项目(ZKYJ-2020003)

Analysis of clinical trial research in Shanghai Jiao Tong University School of Medicine

PENG Shutao¹(), QIU Xiaochun²()

^1.Institute of Medical Education, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
^2.Shanghai Jiao Tong University School of Medicine Library, Shanghai 200025, China

Received:2022-06-16 Accepted:2022-08-10 Online:2022-08-28 Published:2022-10-08
Contact: QIU Xiaochun E-mail:pengshutao@shsmu.edu.cn;tsg2@shsmu.edu.cn
Supported by:
Shanghai Social Science Planning Project(2020BKS003);Shanghai University Think Tank Connotation Construction Plan(20ZKNH040);Think Tank Leading Research Project of Shanghai Jiao Tong University(ZKYJ-2020003)

摘要/Abstract

摘要：

目的·分析2012—2021年上海交通大学医学院（简称上海交大医学院）注册的临床试验与发表的临床研究论文的学科分布、研究团队、多中心合作及其趋势特征。方法·在Dimensions及中国、美国临床试验注册平台重点检索上海交大医学院及附属医院2012—2021年注册开展的临床试验信息，按健康研究分类系统（Health Research Classification System，HRCS）和国际放射防护委员会（International Commission on Radiological Protection，ICRP）肿瘤分类标准等对每条临床试验进行分类与标注。在PubMed数据库中检索同期以上海交大医学院为第一或通信作者所在机构发表的临床研究论文。采用EXCEL 2016和VOSviewer 1.6.18软件对以上信息进行聚类分析和可视化汇总。结果·2012—2021年全球新注册的临床试验中有中国研究人员参与的为54 652项，占全球总数的13.63%。北京、上海、广州是中国开展临床试验研究最多的3个城市。上海交大医学院这10年间每年新注册的与在研的临床试验项目数基本呈现逐年递增趋势，但2021年新注册的项目数略有下降。在所有上海交大医学院注册的3 970项临床试验中，44.4%在中国临床试验平台注册，55.0%在美国临床试验平台注册；85.5%的临床试验由研究者发起；肿瘤、心血管疾病、口腔与胃肠道疾病、精神疾病、代谢与内分泌疾病是该校临床试验研究的重点领域。其中，肺癌研究位列所有47种肿瘤研究的首位。第六人民医院、瑞金医院和仁济医院是临床试验注册数前3位的附属医院。以上海交大医学院为第一或通信作者所在机构的临床研究论文共计1 898篇（5.4%），研究主题主要分布在胃肠病、心脏病、肿瘤、放射、口腔正畸、糖尿病等领域。复旦大学各附属医院是其临床试验合作的主要机构。上海交大医学院在糖尿病、高血压以及骨科、放射科、肾脏科等领域已经形成核心研究团队。结论·上海交大学医学院临床试验研究学科优势明显，新兴学科潜力较大。多学科创新研究团队也已形成，多中心临床试验是临床试验的常态，并已在部分领域主持国际多中心临床试验合作。但相比全球与国内其他地区，2021年该校临床试验注册数有所下降，其原因有待进一步分析。

关键词: 临床试验, 注册, 学科, 可视化分析, 聚类分析

Abstract:

Objective ·To analyze the discipline distribution, research teams, multi-center cooperation and trend of clinical trial registration and published papers of Shanghai Jiao Tong University School of Medicine (SJTUSM) from 2012 to 2021. Methods ·On the Dimensions, and China and US clinical trial registration platforms, the clinical trial information registered by the institutions affiliated to SJTUSM from 2012 to 2021 was retrieved. Each clinical trial was classified and marked according to the classification standards such as Health Research Classification System (HRCS) and International Commission on Radiological Protection (ICRP). Clinical trial papers published by the first author or corresponding author from SJTUSM in the same period were retrieved in PubMed. EXCEL 2016 and VOSviewer 1.6.18 software were used to conduct cluster analysis and visual summary. Results ·From 2012 to 2021, Chinese researchers participated in 54 652 newly registered clinical trials worldwide, accounting for 13.63% of the global in total. Beijing, Shanghai and Guangzhou have been the top three cities with the most clinical trials in China. The number of newly registered and underdeveloped clinical trial projects in SJTUSM has been basically increased year by year in the past 10 years, but it declined slightly in 2021. In total, 3 970 clinical trials were registered by SJTUSM, in which 44.4% were registered on the Chinese clinical trial platform and 55.0% were registered on the US clinical trial platform, and 85.5% were initiated by researchers. Cancer, cardiovascular disease, oral and gastrointestinal disease, mental disease, and metabolic and endocrine disease were the major areas of clinical trial research of SJTUSM. Lung cancer research ranked the first in all 47 kinds of tumor research. The Sixth People 's Hospital, Ruijin Hospital and Renji Hospital ranked top 3 in clinical trial registration among hospitals affiliated to SJTUSM. A total of 1 898 papers (5.4%) were published in clinical trials with SJTUSM as the first author 's or correspondent author 's institution, and the research topics were mainly distributed in the fields of gastroenterology, heart disease, tumor, radiation, orthodontics and diabetes. The affiliated hospitals of Fudan University has been the main institutions of clinical trial cooperation. SJTUSM has formed core research teams in the fields of diabetes, hypertension, orthopedics, radiology and nephrology. Conclusion ·SJTUSM has obvious advantages in clinical trial research discipline and a great potential for emerging disciplines. Innovative clinical research teams have been formed in SJTUSM. Multi-center clinical trials are the norm of clinical trials, and SJTUSM has presided over international multi-center clinical trial cooperation in some fields. However, compared with the clinical trial registration in the world and other domestic regions in 2021, the number of clinical trial registrations of SJTUSM has decreased significantly, and the reasons need to be further analyzed.

Key words: clinical trial, registration, discipline, visual analysis, cluster analysis

中图分类号:

彭树涛, 仇晓春. 上海交通大学医学院临床试验研究现状分析[J]. 上海交通大学学报（医学版）, 2022, 42(8): 971-979.

PENG Shutao, QIU Xiaochun. Analysis of clinical trial research in Shanghai Jiao Tong University School of Medicine[J]. Journal of Shanghai Jiao Tong University (Medical Science), 2022, 42(8): 971-979.

图/表 9

图1 2012— 2021年全球与中国临床试验注册数

Fig 1 Number of clinical trial registrations in the world and in China from 2012 to 2021

图2 2012— 2021年北京、上海与广州的临床试验注册数

Fig 2 Number of clinical trial registrations in Beijing, Shanghai and Guangzhou from 2012 to 2021

图3 2012— 2021年上海交大医学院临床试验数

Fig 3 Clinical trials of Shanghai Jiao Tong University School of Medicine (SJTUSM) from 2012 to 2021

图4 2012— 2021年上海交大医学院临床试验数量最多的前 5个专业领域

Fig 4 Top 5 professional fields with the largest number of clinical trial researches of SJTUSM from 2012 to 2021

图5 2012— 2021年上海交大医学院肿瘤临床试验数量排名的前 5个类型

Fig 5 Top 5 types of cancer clinical trials of SJTUSM from 2012 to 2021

图6 2012— 2021年上海交大医学院各附属医院注册的临床试验数Note： 6th Hosp—Sixth People 's Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hosp—Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Renji Hosp—Renji Hospital, Shanghai Jiao Tong University School of Medicine; 9th Hosp—Ninth People 's Hospital, Shanghai Jiao Tong University School of Medicine; Xinhua Hosp—Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; General Hosp—General Hospital, Shanghai Jiao Tong University School of Medicine; Chest Hosp—Chest Hospital, Shanghai Jiao Tong University School of Medicine; SMHC—Mental Health Center, Shanghai Jiao Tong University School of Medicine; Children 's Med CTR—Children 's Medical Center, Shanghai Jiao Tong University School of Medicine; Children 's Hosp—Children 's Hospital, Shanghai Jiao Tong University School of Medicine; IPMCH—International Peace Maternity and Child Health Hospital, Shanghai Jiao Tong University School of Medicine; Tongren Hosp—Tongren Hospital, Shanghai Jiao Tong University School of Medicine.

Fig 6 Number of registered clinical trials in affiliated hospitals of SJTUSM from 2012 to 2021

图7 2012— 2021年上海交大医学院临床研究论文主题分布

Fig 7 Themes of clinical research of SJTUSM from 2012 to 2021

图8 2012— 2021年上海交大医学院临床研究机构合作图谱

Fig 8 Cooperative atlas of clinical research institutions with SJTUSM from 2012 to 2021

图9 2012— 2021年上海交大医学院临床论文主要作者研究领域分布

Fig 9 Research fields distribution of main authors of clinical research in SJTUSM from 2012 to 2021

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上海交通大学医学院临床试验研究现状分析

Analysis of clinical trial research in Shanghai Jiao Tong University School of Medicine

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