Optimization of drug management model for investigator-initiated trial with benchmarking analysis
- VernacularTitle:对标分析法优化研究者发起的临床研究用药品管理模式
- Author:
Yufei XI
1
;
Tianxiao WANG
2
;
Xue ZHANG
1
;
Yingzhuo DING
1
;
Li YAN
1
;
Feng JIANG
1
;
Xiangui HE
2
;
Jiannan HUANG
3
;
Qin LI
1
Author Information
1. Dept. of Pharmacy，Shanghai Eye Diseases Prevention & Treatment Center/Shanghai Eye 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
- Publication Type:Journal Article
- Keywords:
investigator-initiated trial;
medical and health
- From:
China Pharmacy
2025;36(3):280-284
- CountryChina
- Language:Chinese
-
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 established， which helps to improve the institutional X2023076） framework of medical institutions in this field.
