药物临床试验过程中试验用药物管理存在的问题研究

Research on the Problems Existing in the Management of Trial Drugs in the Process of Drug Clinical Trials

目的分析药物临床试验时对试验所需药物展开管理过程中存在的问题并对存在的问题提出针对性解决措施。方法收集相关数据信息,分析当前药物临床试验时存在的药物管理问题,并将问题归纳总结后,制定合理的解决措施。结果观察组分发环节问题2例、回收环节问题1例,药品管理存在问题总发生3例,观察组药品管理存在问题发生率为12.50%。对照组接受环节问题1例、储存环节问题2例、分发环节问题2例、使用环节问题2例、回收环节问题3例,药品管理存在问题总发生10例,药品管理存在问题的发生率为41.67%。两组对比,差异有统计学意义(P<0.05)。结论临床药物试验的过程中,会发生不同的药物管理问题,各单位需完善自身的药物管理制度,积极预防可能出现的问题,保证试验的准确性。

Objective To analyze the problems existing in the management of the drugs needed for the trial during drug clinical trials and propose targeted solutions to the existing problems.Methods Collected relevant data and information,analyze the current drug management problems in drug clinical trials,and formulate reasonable solutions after the problems are summarized.Results In the observation group,there were 2 cases of problems in distribution and 1 case of problems in recovery,there were 3 cases of problems in drug management,the incidence of problems in drug management in the observation group was 12.50%.In the control group,there were 1 case of receiving link problems,2 cases of storage link problems,2 cases of distribution link problems,2 cases of use link problems and 3 cases of recovery link problems,there were 10 cases of drug management problems,and the incidence of drug management problems was 41.67%.There was significant difference between the two groups(P<0.05).Conclusion In the process of clinical drug trials,different drug management problems will occur.Each unit needs to improve its own drug management system,actively prevent possible problems,and ensure the accuracy of the trial.