目的·分析2015—2023年上海交通大学医学院（简称“交医”）高水平临床研究发展趋势及现状，并对交医临床研究水平的提升策略进行总结，旨在为医学院校推动高水平临床研究提供参考。方法·在Web of Science核心合集数据库中，检索发表时间为2015—2023年，以交医（含附属医院）作为第一作者所在机构发表的论文。利用一般描述性方法分析临床研究论文发表、临床试验注册、临床研究人才队伍、临床研究合作现况；运用文献计量方法对检索到的临床研究论文的国际合作、主题分布等进行可视化分析；对2015—2018年与2019—2023年两个时间段，交医在临床研究领域发文数、Q1区发文数、顶尖临床医学期刊发文数和专职科研人员数量方面的差异进行比较和分析。结果·2015—2023年，以交医为第一作者所在机构发表的临床研究论文共计9 468篇，年发文量呈逐年上升趋势；2015—2023年，交医临床研究Q1区发文数、顶尖临床医学期刊发文数、美国临床试验注册平台和中国临床试验注册中心注册的临床研究数、临床指南和专家共识发布数、专职科研队伍人数以及国家级人才新增人数均呈整体上升趋势；肿瘤、心脑血管疾病等重大慢性病为主要研究热点。临床研究论文中，1 308篇（13.82%）为国际合作论文，其中以美国（733篇）、澳大利亚（137篇）、英国（99篇）等发达国家/地区与交医合作论文居多。2019—2023年与2015—2018年相比，交医在临床研究论文数、Q1区发文数、顶尖临床医学期刊发文数和附属医院新增专职科研人数方面比较，均显著增加（均P<0.05）。结论·交医强化顶层设计，围绕重大疾病进行深入探索，以“平台-人才-方法学”为路径，构建了体系化、一体化和闭环式的临床研究水平提升模式，相继产出了一批高质量的临床研究成果。

Objective ·To analyze the development trend and current situation of high-level clinical research at Shanghai Jiao Tong University School of Medicine (SJTUSM) from 2015 to 2023, and to summarize the strategies for improving clinical research capability of SJTUSM, aiming to provide reference and inspiration for medical universities to promote high-level clinical research. Methods ·Papers published by first authors from SJTUSM or its affiliated hospitals during this period were retrieved in the Web of Science core collection database. General descriptive methods were used to quantify the number of clinical research papers, registered clinical trials, clinical research talent teams, and the current status of clinical research cooperation. Bibliometric methods were used to visualize the international collaboration and topic distribution of retrieved clinical research papers. The differences in the number of clinical research publications, Q1 publications, publications in top clinical medical journals, and full-time researchers between the periods of 2015?2018 and 2019?2023 were compared and analyzed. Results ·From 2015 to 2023, a total of 9 468 clinical research papers were published by SJTUSM or its affiliated hospitals as the first author′s institution, showing an increasing trend year by year. During this period, the number of Q1 publications of SJTUSM′s clinical research, publications in top clinical medical journals, clinical studies registered on the United States Clinical Trial Registry website, clinical studies registered on the Chinese Clinical Trial Registry website, clinical guidelines and expert consensus publications, full-time research team members, and newly added national-level talents all showed an overall upward trend. Tumors, cardiovascular and cerebrovascular diseases, major chronic diseases, and mental illnesses were the main research hotspots. A total of 1 308 papers (13.82%) were international collaborative papers. Developed countries/regions such as the United States (733 papers), Australia (137 papers), and the United Kingdom (99 papers) were closely cooperating with SJTUSM. From 2019 to 2023, there was a significant increase in the number of clinical research papers, Q1 publications, publications in top clinical medical journals, and newly added full-time research team members in affiliated hospitals compared to the period from 2015 to 2018 (all P<0.05). Conclusion ·SJTUSM has strengthened top-level design, conducted in-depth major diseases, and constructed a systematic, integrated and closed-loop model for enhancing clinical research level along the “platform-talent-methodology” pathway, resulting in a number of high-quality clinical research outcomes.