药物临床试验监查质量管理研究

发布时间：2018-04-12 12:46

本文选题：临床试验 + 监查　；参考：《暨南大学》2014年硕士论文

【摘要】：药物临床试验作为新药开发中至关重要的一步，对新药研究开发及药品上市具有重大的作用和意义，试验质量的高低直接影响药物能否通过审评并成功注册。监查作为监督和检查临床试验过程的一个行为，是保证临床试验质量的重要环节，能够保证试验按照试验方案、标准操作规程（standard operating procedure,SOP）和相关法规进行，保障临床试验中受试者的权益，保证试验数据准确、完整，对临床试验质量控制具有重要影响。通过监查，及时发现临床试验实施过程中存在的问题，从而加以纠正解决，不断提高临床试验的质量。本文探讨和分析监查中发现的主要问题及原因，并提出建议和对策，为指导临床试验监查工作，提高临床试验质量提供一定的参考。本论文共抽取836份临床试验项目监查报告，以监查报告所属的临床试验项目的药物种类、试验分期、访视时期作为分类标准，对监查报告所反映的问题进行分析归纳，记录于监查报告记录问题提取表，分析并比较不同药物种类、不同临床试验分期的临床试验在实施过程中出现问题的异同，以及在不同的监查访视阶段，监查所发现的问题的异同。通过基于频数分析和卡方检验的监查报告记录问题的亚组研究，发现研究病历/CRF填写不及时/不完整、入组进度缓慢是监查过程中发现的最常见问题，不同的临床试验因为试验特点不同，影响试验质量的问题发生情况有所差异。在监查过程中，我们应当根据不同的试验特点制定具体化的监查计划。利用电子数据采集系统，采取基于风险分析的集中化监查将会是未来监查模式的发展趋势。除此之外，我们还可以通过建立监查指导性文件、建立监查员管理制度、大力推广临床研究协调员模式等方法提高监查的效率和质量，，从而提高临床试验的质量。
[Abstract]:As a crucial step in the development of new drugs, the clinical trial of drugs plays an important role and significance in the research and development of new drugs and the marketing of drugs. The quality of the trials directly affects whether the drugs can be evaluated and registered successfully.As an act of supervising and checking the clinical trial process, supervision and inspection is an important part of ensuring the quality of the clinical trial. It can ensure that the trial is carried out in accordance with the test plan, standard operating procedures, standard operating procedure and related regulations.Ensuring the rights and interests of the subjects in clinical trials and ensuring the accuracy and integrity of test data have an important impact on the quality control of clinical trials.The problems existing in the implementation of clinical trials can be found in time by monitoring, and the quality of clinical trials can be improved continuously.This paper discusses and analyzes the main problems and causes found in the monitoring and inspection, and puts forward some suggestions and countermeasures, which provides a certain reference for guiding the monitoring of clinical trials and improving the quality of clinical trials.In this paper, a total of 836 clinical trial project inspection reports were extracted, and the problems reflected in the monitoring report were analyzed and summarized with the drug types, trial stages and interview periods of the clinical trial items to which the monitoring reports belong as the classification criteria.Record the problem extraction table in the monitoring report, analyze and compare the similarities and differences between different drug types, clinical trials of different stages of clinical trials in the course of implementation, and at different monitoring and visiting stages,The similarities and differences of the problems found by the supervisor.Based on frequency analysis and chi-square test, the subgroup study of monitoring report record problem shows that the research case record / CRF filling is not timely / incomplete, and the slow progress of group entry is the most common problem found in the process of monitoring inspection.Problems affecting the quality of clinical trials vary according to the characteristics of the trials.In the process of monitoring, we should make specific inspection plan according to different experimental characteristics.Using electronic data acquisition system and adopting centralized monitoring based on risk analysis will be the development trend of monitoring mode in the future.In addition, we can improve the efficiency and quality of the inspection by establishing the supervisory guidance document, establishing the supervisor management system, and popularizing the model of clinical research coordinator, so as to improve the quality of clinical trials.
【学位授予单位】：暨南大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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