Construction and Exploration of Management Model for Anti-cancer Drugs Medicated in Clinical Trials
10.3870/j.issn.1004-0781.2024.07.026
- VernacularTitle:临床试验用抗肿瘤药物管理模式构建与探索
- Author:
Zhaocong WANG
1
;
Feng ZHANG
;
Fang XU
;
Tianen LI
;
Xueyan WEI
;
Xinhong WU
Author Information
1. 华中科技大学同济医学院附属肿瘤医院,湖北省肿瘤医院药物临床试验机构,武汉 430079
- Keywords:
Anti-cancer drugs;
Clinical trials;
Central pharmacy;
Drug management
- From:
Herald of Medicine
2024;43(7):1161-1164
- CountryChina
- Language:Chinese
-
Abstract:
Objective To summarize experience of anti-cancer drug management for clinical trials,and to explore a more efficient and standardized management model of anti-cancer drugs used in clinical trials.Methods Based on our current work in central pharmacy,the particularity and complexity of anti-cancer drug management for clinical trials were analyzed.In the meantime,we identified high-risk parts in the drug management process.Based on those risks,feasible measures were taken and presented in detail.Results Management of anti-cancer drugs used in clinical trials has its characteristics,such as long cycle,low error-tolerant rate,closed-loop model,etc.Recognizing these representative high-risk parts during the trials and making responses,including standardization of drug management records and disposition of drugs and packaging returned by subjects,should be achieved as soon as possible.Conclusion Establishing and observing strict rules and regulations,improving the hardware and software performance of the central pharmacy as well as implementing risk-based drug management is beneficial to conduct clinical trials normatively.