發(fā)布時間：2018-03-03 06:29

  本文選題：藥物臨床試驗　切入點：質(zhì)量控制　出處：《中國藥房》2017年22期 　論文類型：期刊論文

【摘要】：目的:發(fā)現(xiàn)影響我院藥物臨床試驗質(zhì)量關(guān)鍵環(huán)節(jié),探討提升藥物臨床試驗質(zhì)量的對策。方法:調(diào)取2014年我院藥物臨床試驗機(jī)構(gòu)10個專業(yè)14次藥物臨床試驗研究質(zhì)量檢查結(jié)果,參照歐洲藥品管理署檢查發(fā)現(xiàn)問題的分級分類方法,對發(fā)生問題的關(guān)鍵環(huán)節(jié)進(jìn)行分析,并評價對關(guān)鍵環(huán)節(jié)采取干預(yù)措施的效果。結(jié)果:2014年發(fā)現(xiàn)重要和一般問題總數(shù)共125例次,其中病例報告表填寫、受試者知情同意、受試者入選和篩查、研究藥物管理等4個環(huán)節(jié)發(fā)現(xiàn)質(zhì)量問題數(shù)占全部問題數(shù)的79.20%,這些環(huán)節(jié)是影響藥物臨床試驗質(zhì)量的關(guān)鍵環(huán)節(jié)。通過采取加強(qiáng)研究者相關(guān)知識培訓(xùn)、完善制度和標(biāo)準(zhǔn)操作規(guī)程管理、加強(qiáng)環(huán)節(jié)質(zhì)量控制、引入項目臨床研究協(xié)調(diào)員、實行中心化藥物管理等干預(yù)措施,2015年和2016年發(fā)現(xiàn)重要和一般問題總數(shù)分別為68、59例次,與2014年比較差異均有統(tǒng)計學(xué)意義(P0.05);2015年和2016年發(fā)現(xiàn)重要問題數(shù)分別為7、4例次,與2014年發(fā)現(xiàn)4例次重要問題數(shù)比較差異均無統(tǒng)計學(xué)意義(P0.05);2014-2016年均無嚴(yán)重問題發(fā)生。對于藥物臨床試驗項目復(fù)雜程度較低的專業(yè),通過采取干預(yù)措施后,2016年發(fā)現(xiàn)質(zhì)量問題數(shù)明顯下降,與2014年比較差異有統(tǒng)計學(xué)意義(P0.05);對于藥物臨床試驗項目復(fù)雜程度較高的專業(yè),2016年發(fā)現(xiàn)質(zhì)量問題數(shù)沒有明顯下降,與2014年比較差異無統(tǒng)計學(xué)意義(P0.05)。結(jié)論:通過管控藥物臨床試驗過程中關(guān)鍵環(huán)節(jié),可明顯減少藥物臨床試驗中一般問題的發(fā)生,但對重要問題的發(fā)生影響不大。不同專業(yè)承擔(dān)藥物臨床試驗項目復(fù)雜程度有區(qū)別,發(fā)生問題的環(huán)節(jié)和程度也有所不同,應(yīng)在質(zhì)量控制檢查中加以區(qū)分。
[Abstract]:Objective: to find out the key links affecting the quality of drug clinical trials in our hospital, and to explore the countermeasures to improve the quality of drug clinical trials. Methods: in 2014, the results of 14 drug clinical trials of 10 specialties in our hospital were obtained. According to the classification method of the European Drug Administration, the key links of the problems were analyzed and the effect of intervention on the key links was evaluated. Results: in 2014, the total number of important and general problems was 125. Among them, the case report form was filled out, the subjects were informed consent, the subjects were selected and screened, The study of drug management and other four links found that the number of quality problems accounted for 79.20% of the total number of problems. These links are the key links affecting the quality of drug clinical trials. Through strengthening the training of researchers' relevant knowledge, perfecting the management of the system and standard operating procedures, Strengthening link quality control, introducing project clinical research coordinator and implementing intervention measures such as centralized drug management, the total number of important and general problems found in 2015 and 2016 were 68 / 59, respectively. Compared with 2014, the difference was statistically significant (P 0.05), and the number of important problems found in 2015 and 2016 was 7 / 4, respectively. There was no significant difference in the number of major problems between 2014 and 2014. There were no serious problems in 2014-2016. After taking intervention measures, the number of quality problems was obviously decreased in 2016, compared with 2014, the difference was statistically significant (P 0.05). For the specialty with high complexity of drug clinical trial items, the number of quality problems did not decrease obviously in 2016. There was no significant difference between 2014 and 2014. Conclusion: by controlling the key links in the clinical trial of drugs, the occurrence of general problems in clinical trials of drugs can be significantly reduced. However, it has little influence on the occurrence of important problems. There are differences in the complexity of clinical trials of drugs in different specialties, and the links and degrees of problems are also different, which should be distinguished in quality control inspection.
【作者單位】： 深圳市第二人民醫(yī)院藥物臨床試驗機(jī)構(gòu)辦公室;
【基金】：深圳市戰(zhàn)略性新興產(chǎn)業(yè)發(fā)展專項資金2013年第五批扶持計劃(No.生物產(chǎn)業(yè)類第17號)
【分類號】：R95

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