辽宁省药物临床试验机构实施备案制后发展现状分析
作者:
作者单位:

1.大连大学附属中山医院,药物临床试验机构办公室,辽宁 大连,116001;2.大连大学附属中山医院,肿瘤科,辽宁 大连,116001

作者简介:

任丹丹,女,硕士研究生,研究方向为药物质量控制。

通讯作者:

李响,男,硕士,副主任医师,研究方向为恶性肿瘤的诊断和综合治疗。

中图分类号:

R95

基金项目:


Analysis of the current development status of drug clinical trial institutions in Liaoning Province after implementing the registration system
Author:
Affiliation:

1.Office of Clinical Drug Trial Institutions, Affiliated Zhongshan Hospital of Dalian University, Dalian, 116001, Liaoning, China;2.Department of Oncology, Affiliated Zhongshan Hospital of Dalian University, Dalian, 116001, Liaoning, China

Fund Project:

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    摘要:

    目的 了解备案制实施后辽宁省药物临床试验机构的发展现状及存在问题,为后续辽宁省药物临床试验机构的发展提供数据支撑及针对性建议。方法 检索国家药品监督管理局官网、国家药物临床试验机构备案管理信息平台以及药物临床试验登记与信息公示平台,对辽宁省药物临床试验机构备案数量、地区分布、级别类型、经营性质、备案专业、备案主要研究者、承接项目、药物类型等进行统计分析。结果 辽宁省药物临床试验机构在备案制实施后取得显著进展,机构总数提升至资格认定管理期间的1.66倍,承接项目总数增长189.73%,但仍存在全国范围内排名不高、资源分布不均等问题。结论 建议通过政策倾斜与资金支持、推动资源下沉、建立规范化培训平台、鼓励跨区域合作等措施,促进辽宁省药物临床试验机构均衡发展。同时,机构也应加强自身建设,聚焦申办方需求,提高竞争力,在追求高速增长的同时也要重视质量监管,共同推动我省药物临床试验机构规范化、科学化发展。

    Abstract:

    Objective To understand the current development status and existing problems of drug clinical trial institutions in Liaoning Province after the implementation of the registration system, and to provide data support and targeted suggestions for the future development of drug clinical trial institutions in our province.Methods By retrieving information from the official website of the National Medical Products Administration, the National Drug Clinical Trial Institution Registration Management Information Platform, and the Drug Clinical Trial Registration and Information Disclosure Platform, statistical analysis was conducted on the number of registered drug clinical trial institutions in Liaoning Province, regional distribution, level and type, business nature, registered specialties, principal investigators, contracted projects, and drug types.Results Liaoning Province's drug clinical trial institutions have made significant progress after the implementation of the registration system. The total number of institutions has increased to 1.66 times that during the qualification recognition management period. The total number of projects undertaken has increased by 189.73%. However, there are still problems of low national ranking and uneven resource distribution. Discussion It is recommended to promote resource allocation to lower-level areas through policy support and financial assistance, establish standardized training platforms, and encourage cross-regional cooperation to facilitate balanced development of drug clinical trial institutions in Liaoning Province. Meanwhile, institutions should also strengthen their self-construction, focus on sponsor needs, and improve their competitiveness. While pursuing rapid growth, they should also attach importance to quality supervision to jointly promote the standardized and scientific development of drug clinical trial institutions in our province.

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任丹丹,李响.辽宁省药物临床试验机构实施备案制后发展现状分析[J].肿瘤药学,2025,15(4):480-485 ( in Chinese)

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  • 在线发布日期: 2025-10-14
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