本文選題：藥物臨床試驗(yàn) + 方案偏離��； 參考：《中國(guó)藥房》2017年25期

【摘要】：目的:研究藥物臨床試驗(yàn)實(shí)施中方案偏離的影響要素,為提高藥物臨床試驗(yàn)的質(zhì)量提供參考。方法:對(duì)重慶醫(yī)科大學(xué)附屬第一醫(yī)院2010-2016年開展的藥物臨床試驗(yàn)項(xiàng)目進(jìn)行質(zhì)量核查,對(duì)各年度方案偏離進(jìn)行回顧性研究并歸類分析,探討方案偏離的類別、例數(shù),并比較國(guó)際與國(guó)內(nèi)試驗(yàn)項(xiàng)目以及是否有專職研究護(hù)士參與試驗(yàn)管理后方案偏離的差異,并提出改進(jìn)措施。結(jié)果:我院2010-2016年開展藥物臨床試驗(yàn)27項(xiàng)涉及949例病案,方案偏離發(fā)生176例,占比18.55%;7年間方案偏離發(fā)生比例逐年降低。發(fā)生的方案偏離類別主要為觀察/評(píng)價(jià)記錄不全(30.11%)、檢查漏項(xiàng)/"超窗"(28.41%)、不良事件及合并用藥不當(dāng)(14.20%)和藥物管理存在疏漏(11.93%);有專職研究護(hù)士參與的項(xiàng)目方案偏離發(fā)生比例低于沒有專職研究護(hù)士參與的項(xiàng)目(11.11%vs.28.67%,P0.01);國(guó)際多中心項(xiàng)目方案偏離發(fā)生比例低于國(guó)內(nèi)項(xiàng)目(6.60%vs.28.84%,P0.01)。結(jié)論:建議應(yīng)有針對(duì)性地加強(qiáng)藥物臨床試驗(yàn)中的薄弱環(huán)節(jié),如臨床試驗(yàn)機(jī)構(gòu)應(yīng)建立臨床試驗(yàn)數(shù)據(jù)留存制度,電子數(shù)據(jù)及時(shí)異地備份等。此外,臨床試驗(yàn)機(jī)構(gòu)應(yīng)盡量配備各專業(yè)專職研究護(hù)士,學(xué)習(xí)和借鑒國(guó)際多中心臨床試驗(yàn)項(xiàng)目試驗(yàn)設(shè)計(jì)嚴(yán)謹(jǐn)科學(xué)、操作流程標(biāo)準(zhǔn)化及數(shù)據(jù)處理真實(shí)等做法,以切實(shí)減少方案偏離的發(fā)生,提高藥物臨床試驗(yàn)的質(zhì)量。
[Abstract]:Objective: to study the influencing factors of program deviation in drug clinical trials, and to provide reference for improving the quality of drug clinical trials. Methods: the quality of the drug clinical trial project carried out in the first affiliated Hospital of Chongqing Medical University from 2010 to 2016 was verified. The deviation of each annual program was retrospectively studied and analyzed, and the categories and cases of the project deviation were discussed. The differences between international and domestic experimental projects and whether there are full-time research nurses involved in experimental management were compared and the improvement measures were put forward. Results: 27 clinical trials involving 949 medical cases were carried out in our hospital from 2010 to 2016, 176 cases of project deviation occurred, accounting for 18.55% of the seven years the proportion of project deviation decreased year by year. The main categories of programme deviations occurred were incomplete observation / evaluation records (30.11%), missing items / "window" (28.41%), adverse events and combined improper use of drugs (14.20%) and drug management omissions (11.93%), and those with full-time research nurses participated in the project deviation occurred. The proportion was lower than that of non-full-time research nurses (11.11vs.28.67P0.01), and the proportion of international multi-center project deviation was lower than that of domestic project (6.60vs.28.84P0.01). Conclusion: it is suggested that the weak links in clinical trials should be strengthened, such as the establishment of clinical trial data retention system and the timely backup of electronic data. In addition, clinical trial institutions should be equipped with professional full-time research nurses as far as possible, and learn from the practice of rigorous and scientific design of international multi-center clinical trial projects, standardization of operation procedures and authenticity of data processing, etc. In order to reduce the occurrence of program deviation, improve the quality of drug clinical trials.
【作者單位】： 重慶醫(yī)科大學(xué)附屬第一醫(yī)院呼吸科;四川大學(xué)華西口腔醫(yī)院正畸科;
【基金】：重慶醫(yī)科大學(xué)附屬第一醫(yī)院護(hù)理科研基金項(xiàng)目(No.HLJJ2014-08)
【分類號(hào)】：R95

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