地级市公立医院药物临床试验机构建设现状与思考——以潮州市人民医院为例

Status and Reflections on the Construction of Drug Clinical Trial Institutions in Public Hospitals at the Prefecture-Level City—A Case Study of Chaozhou People’s Hospital

摘要: 目的：以潮州市人民医院为例，探讨地级市公立医院药物临床试验机构建设的现状与问题，并提出发展对策。方法：通过文献分析、医院2021~2025年运营数据回顾、广东省药物临床试验机构备案数据横向对比及问卷调查等方法，从人才队伍、受试者招募、资金投入、信息化建设、项目承接等方面进行系统分析。结果：潮州市目前共有2家医院完成药物临床试验机构备案，潮州市人民医院于2024年3月完成2个专业组备案，至今仅承接项目1项，处于起步阶段。与省内同类地级市相比，潮州市在备案专业数、年均项目承接量等核心指标上均排名相对靠后，信息化建设亦明显滞后。文献分析及问卷调查显示，地级市公立医院在机构建设方面普遍面临人才储备不足、激励机制缺失、受试者认知度低、信息化建设滞后、项目获取困难等突出问题，且潮汕地区文化背景进一步加剧了受试者招募难度。结论：潮州市人民医院的实践表明，处于起步阶段的地级市公立医院药物临床试验机构应在政策争取、人才引育、科普宣教、信息化建设、项目拓展等方面综合施策，逐步提升机构建设水平，为区域医药创新发展提供支撑。

Abstract: Objective: To investigate the current status and challenges in the establishment of drug clinical trial institutions in prefecture-level public hospitals, using Chaozhou People’s Hospital as an example, and to propose corresponding development strategies. Methods: Through literature analysis, a retrospective review of the hospital’s operational data from 2021 to 2025, a horizontal comparison with registration data of drug clinical trial institutions in Guangdong Province, and a questionnaire survey, a systematic analysis was conducted covering the talent team, subject recruitment, financial investment, information technology (IT) development, and project acquisition. Results: Currently, only two hospitals in Chaozhou have completed the registration of drug clinical trial institutions. Chaozhou People’s Hospital completed the registration of two specialty groups in March 2024 and has undertaken only one project to date, indicating that it is still in its infancy. Compared with similar prefecture-level cities in Guangdong Province, Chaozhou ranks relatively low in core indicators such as the number of registered specialties and the average annual number of undertaken projects, while its IT infrastructure development also lags noticeably behind. Literature analysis and the questionnaire survey revealed that prefecture-level public hospitals generally face prominent challenges in institution building, including insufficient talent reserves, a lack of incentive mechanisms, low public awareness of clinical trials among potential subjects, lagging IT infrastructure, and difficulties in obtaining projects; moreover, the cultural context of the Chaoshan region further exacerbates the difficulty of subject recruitment. Conclusion: The experience of Chaozhou People’s Hospital demonstrates that drug clinical trial institutions in prefecture-level public hospitals at the initial stage of development should adopt comprehensive measures in policy advocacy, talent introduction and cultivation, science popularization and public education, IT infrastructure development, and project expansion, so as to progressively enhance the level of institution building and provide support for regional pharmaceutical innovation and development.