我院药物临床试验实施质量回顾性分析

目的:评价我院药物临床试验的实施质量,探讨临床试验实施中的不足,并提出有针对性的改进措施。方法:根据2007-2013年我院药物临床试验项目的质控记录,对照项目实施质量评分标准,分析临床试验质量得分以及各要素的得分情况。并分别对实行和未实行临床研究协调员(CRC)制的A科室和B科室,以及国际多中心和同期国内多中心项目的实施质量进行比较。结果:我院药物临床试验质量得分逐年提高,2013年达90.4分,比2007年增加了1倍;但2013年有3个要素的得分率低于90%,分别为试验实施、试验药物管理和试验记录。A科室项目完成质量得分均高于B科室;2011-2013年A科室的优势要素(得分率差异>15%)显著优于B科室,主要为试验实施(98.8%vs.75.0%)、试验药物管理(100%vs.83.0%)、试验记录(89.9%vs.63.0%)和试验资料管理(100%vs.81.2%),均P<0.01。国际多中心项目实施质量得分高于国内(94.7分vs.83.0分),P<0.01。结论:我院临床试验的薄弱环节主要为试验实施、试验药物管理和试验记录。而CRC制的推广以及国际多中心临床试验的承接是解决以上薄弱环节、提高临床试验质量的有效措施。

Retrospective Analysis of the Quality of Clinical Drug Trial in Our Hospital

OBJECTIVE： To evaluate the quality of clinical drug trials in our hospital and explore their problems in order to put forward improvement measures. METHODS： According to quality control records in our hospital from 2007 to 2013, comparing with the standards for project quality scoring, the quality scoring of clinical trials and factor scoring were analyzed. In addition, the qualities of clinical drug trials were compared between department A with clinical research coordinator （CRC） and department B without CRC, as well as between international and domestic multicenter trails. RESULTS ： Generally, the quality scoring of clinical drug trials in our hospital improved year by year, being 90.4 in 2013 which was 1 fold higher than that in 2007. The score rates of 3 quality items in 2013 were fewer than 90%, such as trail implementation, trial drug management and trail record. The quality scoring of department A was higher than that of department B. The advantage factors of department A during 2011 -2013 （the difference rate of score〉15% ） was significantly better than those of department B, such as the implementation of trail （98.8% vs. 75.0% ） , management of trial drug （100% vs. 83.0% ） , trail record （89.9% vs. 63.0% ） , document management （100% vs. 81.2% ）, with P〈0.01. The international multicenter trails had better quality than domestic ones （94.7 points vs. 83.0 points）, with P〈0.01. CONCLUSIONS： The weak points of clinical drug trial in our hospital are the implementation of trail, trial drug management and trail record. The implementation of CRC and the undertaking of international multicenter trail are effective countermeasures to solve the above weakness and promote the quality of clinical drug trial.