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试验药品管理的重要性,在于这些药物多未上市,其安全性和有效性有一定的不确定性。临床试验用药品的管理和使用是否规范,直接影响到试验结果的可靠性和受试者的用药安全,同时也是药监部门每次检查临床试验的重要内容。试验用药品具体管理流程包括药品的接收、存储、发放、回收等诸多环节,在管理上任何一个环节的疏忽,都会对整个试验产生生严重影响,甚至导致试验失败。为此,应建立试验药品管理制度,配备相应的储存设施和条件,并对试验药品管理人员进行培训。不论对临床试验的设计者、研究者、管理者而言,认识到试验药品管理的重要性,对于提高临床试验质量,保障受试者的用药安全都大有裨益。
The importance of trial drug management lies in the fact that many of these drugs are not yet available and their safety and effectiveness are subject to certain uncertainties. Whether the administration and use of clinical trial drugs are standardized will directly affect the reliability of the test results and the medication safety of the subjects, and it is also an important content of every inspection of clinical trial by the drug control department. The specific management process of the trial drug includes many aspects such as the receipt, storage, distribution and recovery of the drug. Any negligence in the management of the trial drug will have a serious impact on the entire trial and may even lead to the failure of the trial. To this end, the establishment of experimental drug management system, with the appropriate storage facilities and conditions, and experimental drug management personnel training. Regardless of the designers, researchers and managers of clinical trials, recognizing the importance of trial drug management is of great benefit to improving the quality of clinical trials and ensuring the medication safety of subjects.