Page 30 - 《中国药房》2025年3期

对标分析法优化研究者发起的临床研究用药品管理模式
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席宇飞 ，王天笑 ，张 雪 ，丁英卓 ，闫 莉 ，江 峰 ，何鲜桂 ，黄建南 ，李 琴 （1.上海市眼病防治中心/
1， 4 #
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同济大学医学院上海市眼科医院药剂科，上海 200331；2.上海市眼病防治中心/同济大学医学院上海市眼科医
院临床研究中心，上海 200331；3.上海市眼病防治中心/同济大学医学院上海市眼科医院眼科，上海 200331；
4.上海交通大学医学院附属第一人民医院药剂科，上海 200080）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2025）03-0280-05
DOI 10.6039/j.issn.1001-0408.2025.03.04
摘 要 目的 优化研究者发起的临床研究（IIT）用药品的管理模式。方法 采用对标分析法，依据上海某三级专科医院在IIT用
药品管理领域的实际工作经验，深入查阅相关法律法规和学术文献，确立标杆，制定评估标准。从临床研究立项开始，通过对研究
药品的接收、储存、分发、使用以及回收等关键环节进行逐一对比分析，梳理当前IIT用药品管理实践存在的不足，并提出优化建
议。结果 经梳理后发现该院的IIT用药品管理存在药品管理员被授权记录缺失、项目执行前培训不足、IIT用药品接收与验收记
录不全等问题。针对存在的问题提出加强对药品管理员的培训、规定具有药师资质的药品管理员才能验收药品等改进措施，完善
相关制度，同时制定了17项IIT用药品管理质控检查要点。结论 本研究初步搭建了医疗机构的IIT用药品管理体系，有助于完善
医疗机构在这一领域的制度框架。
关键词 研究者发起的临床研究；医疗卫生机构；药品管理；对标分析

Optimization of drug management model for investigator-initiated trial with benchmarking analysis
XI Yufei ，WANG Tianxiao ，ZHANG Xue ，DING Yingzhuo ，YAN Li ，JIANG Feng ，HE Xiangui ，HUANG
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Jiannan ，LI Qin （1.Dept. of Pharmacy， Shanghai Eye Diseases Prevention & Treatment Center/Shanghai Eye
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Hospital， School of Medicine， Tongji University， Shanghai 200331， China； 2. Clinical Research Center，
Shanghai Eye Diseases Prevention & Treatment Center/Shanghai Eye Hospital， School of Medicine， School of
Medicine， Tongji University， Shanghai 200331， China； 3. Dept. of Ophthalmology， Shanghai Eye Diseases
Prevention &Treatment Center/Shanghai Eye Hospital， School of Medicine， Tongji University， Shanghai
200331， China； 4. Dept. of Pharmacy， Shanghai General Hospital， Shanghai Jiao Tong University School of
Medicine， Shanghai 200080， China）
ABSTRACT OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial （IIT）. METHODS
With benchmarking analysis， based on the practical work experience of a tertiary specialized hospital in the field of IIT drug
management in Shanghai， a thorough review was conducted， involving relevant laws， regulations， and academic literature to
establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects， a detailed comparative analysis
of key processes was carried out， such as the receipt， storage， distribution， use and recycling of drugs for trial. The deficiencies in
the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS
It was found that the authorized records of drug management were missing， the training before project implementation was
insufficient， and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems，
improvement measures were put forward， including strengthening the training of drug administrators and stipulating that only drug
administrators with pharmacist qualifications be eligible to inspect and accept drugs， etc. The related systems were improved， and
17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug
management system for medical institutions has been
Δ 基金项目 2023 年上海市医院协会医院管理研究基金（No. established， which helps to improve the institutional
X2023076） framework of medical institutions in this field.
＊第一作者 副主任药师。研究方向：临床药学。电话：021- KEYWORDS investigator-initiated trial； medical and health
62982727。E-mail：pharmxi@163.com
institutions； drug management； benchmarking analysis
# 通信作者 副主任药师。研究方向：临床药学、临床药理。电话：
021-63240090。E-mail：liqin0626@hotmail.com

· 280 · China Pharmacy 2025 Vol. 36 No. 3 中国药房 2025年第36卷第3期