上海市药物临床试验机构发展现况分析

Analysis of the Development Status of Drug Clinical Trial Institutions in Shanghai

关键词:  备案制  药物临床试验机构  GCP药房  药物临床试验  问卷调查

Key words:  Filing system  Drug clinical trial institutions  GCP Pharmacy  Drug clinical trials  questionnaire investigation

摘要:

目的 调研临床试验机构备案制后上海市临床试验机构发展现状及存在问题，并提出对策建议。方法 通过查询NMPA网站、备案平台和药物临床试验登记与信息公示平台，并以上海市临床试验机构为调研对象发放问卷，剖析上海市药物临床试验机构的发展现状和存在的问题。结果 共收回问卷13份，有效问卷13份；备案制后上海市在备案平台中登记备案的机构共70家，三甲机构数量最多共36家；在药物类型上，增加最多的是生物制品，中药或天然药物和化学药物增幅不大；除内外科之外，备案机构数最多的科室是肿瘤科，中医科备案机构数也位于前列；自备案制开始以来，新机构、新专业和地址变更的备案数量大大增加。结论 备案制后上海市药物临床试验机构存在医疗资源分布不均，Ⅰ期临床试验研究室资源短缺，机构监督检查工作落实不全等问题。建议 增加药物临床试验机构备案数量，提高临床试验机构知名度的提升意识，提升药物临床试验人员数量和质量，促进Ⅰ期临床试验研究室的建设，加强临床试验机构监管和质量控制。

Abstract:

Objective: Conduct research on the current development status and existing problems of clinical trial institutions in Shanghai after the filing system for clinical trial institutions, and propose countermeasures and suggestions.Methods: By searching the NMPA website, filing platform, and drug clinical trial registration and information disclosure platform, and distributing questionnaires to clinical trial institutions in Shanghai as research subjects, this study analyzes the current development status and existing problems of drug clinical trial institutions in Shanghai.Results: A total of 13 questionnaires were collected, with 13 valid questionnaires. After the filing system, a total of 70 institutions were registered and filed on the filing platform in Shanghai, with a maximum of 36 tertiary institutions; In terms of drug types, the most significant increase is in biological products, while the increase in traditional Chinese medicine, natural medicine, and chemical drugs is not significant; Apart from internal surgery, the department with the highest number of registered institutions is oncology, and the number of registered institutions in traditional Chinese medicine is also among the top; Since the beginning of the self filing system, the number of registrations for new institutions, new majors, and address changes has greatly increased.Conclusion: After the filing system, Shanghai's drug clinical trial institutions have problems such as uneven distribution of medical resources, shortage of resources in Phase I clinical trial laboratories, and incomplete implementation of institutional supervision and inspection work.Suggestions: Increase the number of drug clinical trial institutions registered, enhance the awareness of improving the visibility of clinical trial institutions, improve the quantity and quality of drug clinical trial personnel, promote the construction of Phase I clinical trial laboratories, strengthen the supervision and quality control of clinical trial institutions.