药物临床试验过程中试验用药品管理的若干问题

Several Problems about Drug Management in Drug Clinical Trial Process

目的:为各医院临床试验用药品的管理提供参考。方法:总结现阶段试验用药品管理常见的问题并分析其危害性,针对问题提出解决措施。结果与结论:目前各药物临床试验机构试验用药品的管理尚未见统一的管理模式,对药品管理的重要性认识也各有差异。因而在实际操作中存在若干影响试验的因素,甚至造成不良后果。各机构应制定科学、有效、实用的管理规范及操作流程,提高药品管理质量,保障药物临床试验安全、科学、可靠。

OBJECTIVE： To provide reference for drug management in clinical trial process in hospital. METHODS： To summarize the common problems of current drug control in clinical trial process and analyze their harmfulness. Some countermeasures were put forward to resolve those problems. RESULTS ＆ CONCLUSIONS： At present uniform management mode hasn＇t been established for drug control in clinical trial institutions. Realizations on the importance of drug control are different from one another. There are several factors which affect clinical trials even result in undesirable consequence. The institution should formulate scientific, effective and practical management standards and operation process to improve the quality of drug control and ensure safety, scientificity and reliability of clinical trials.