本文選題：臨床試驗 + 監(jiān)查��； 參考：《暨南大學》2014年碩士論文

【摘要】：藥物臨床試驗作為新藥開發(fā)中至關重要的一步，對新藥研究開發(fā)及藥品上市具有重大的作用和意義，試驗質量的高低直接影響藥物能否通過審評并成功注冊。監(jiān)查作為監(jiān)督和檢查臨床試驗過程的一個行為，是保證臨床試驗質量的重要環(huán)節(jié)，能夠保證試驗按照試驗方案、標準操作規(guī)程（standard operating procedure,SOP）和相關法規(guī)進行，保障臨床試驗中受試者的權益，保證試驗數據準確、完整，對臨床試驗質量控制具有重要影響。通過監(jiān)查，及時發(fā)現臨床試驗實施過程中存在的問題，從而加以糾正解決，不斷提高臨床試驗的質量。本文探討和分析監(jiān)查中發(fā)現的主要問題及原因，并提出建議和對策，為指導臨床試驗監(jiān)查工作，提高臨床試驗質量提供一定的參考。 本論文共抽取836份臨床試驗項目監(jiān)查報告，以監(jiān)查報告所屬的臨床試驗項目的藥物種類、試驗分期、訪視時期作為分類標準，對監(jiān)查報告所反映的問題進行分析歸納，記錄于監(jiān)查報告記錄問題提取表，分析并比較不同藥物種類、不同臨床試驗分期的臨床試驗在實施過程中出現問題的異同，以及在不同的監(jiān)查訪視階段，監(jiān)查所發(fā)現的問題的異同。通過基于頻數分析和卡方檢驗的監(jiān)查報告記錄問題的亞組研究，發(fā)現研究病歷/CRF填寫不及時/不完整、入組進度緩慢是監(jiān)查過程中發(fā)現的最常見問題，不同的臨床試驗因為試驗特點不同，影響試驗質量的問題發(fā)生情況有所差異。 在監(jiān)查過程中，我們應當根據不同的試驗特點制定具體化的監(jiān)查計劃。利用電子數據采集系統(tǒng)，采取基于風險分析的集中化監(jiān)查將會是未來監(jiān)查模式的發(fā)展趨勢。除此之外，我們還可以通過建立監(jiān)查指導性文件、建立監(jiān)查員管理制度、大力推廣臨床研究協(xié)調員模式等方法提高監(jiān)查的效率和質量，，從而提高臨床試驗的質量。
[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.
【學位授予單位】：暨南大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R95

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本文編號：1739818