加强临床试验用药品的管理

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。

Enforced drug management for clinical trials

Importance of test drug management is that many of these drugs are not listed, and their safety and effectiveness have some uncertainty. The trials of the drug management and the use of standard or not, directly relate to the reliability of the test results and the life safety of subjects, but also the administration of each examination is the important content for the clinical trials. The procedure of management in the trials includes receiving, storage, issuance of drug, recycling, as well as many other links. A link to any management oversight will result in the serious influence on the whole trials and even lead to the failure. Therefore, the drug management system for clinical trials equipped with storage facilities and the appropriate conditions should be establishe, and training to the test drug management should be carried on. No matter to the designers, researchers, or managers of the clinical trials, recognizing the importance of the drug management and improving the quality of clinical trials are of the great advantage to guarantee the safety of the subjects drug.