中国药房2017，Vol.28Issue(25)：3474-3478,5.DOI:10.6039/j.issn.1001-0408.2017.25.06
我院药物临床试验实施中方案偏离的回顾性研究
Retrospective Study on the Protocol Deviation in Drug Clinical Trial Implementation of Our Hospital
摘要
Abstract
OBJECTIVE:To study the influencing factors of protocol deviation in drug clinical trial implementation,and pro-vide reference for improving the quality of drug clinical trial. METHODS:Quality verification was conducted for the drug clinical trial projects in the First Affiliated Hospital of Chongqing Medical University during 2010-2016,and protocol deviations in each year were retrospectively studied,classified and analyzed. Category,frequency,international and domestic pilot projects and the differences of protocol deviation after full-time research nurse participating in trail management were explored,and the measures were put forward. RESULTS:27 drug clinical trials were implemented in our hospital during 2010-2016,including 949 cases,176 cases with protocol deviation,accounting for 18.55％. Deviation protocol in drug clinical trial was decreased year by year for 7 years. The categories were mainly incompleteness of observation/records (30.11％),checking omission/"broaden the window"(28.41％),adverse drug events and improper combined medication (14.20％) and omission in drug management (11.93％). The proportion of protocol deviation with full-time research nurse participated was lower than the projects without full-time research nurse(11.11％ vs. 28.67％,P<0.01),and proportion of deviation protocol in international multi-center project was lower than the domestic projects(6.60％ vs. 28.84％,P<0.01). CONCLUSIONS:It is suggested to pointedly strengthen the weak links of drug clinical trial. For example,clinical trial institutions should establish the clinical trial data retention system,electronic data should be timely backed up in a different places,etc. Besides,clinical trial institutions should equip professional full-time research nurses as much as possible,learn the rigorous scientific experimental design,standard operational procedures and the authenticity of data pro-cessing from the international multi-center clinical trial projects to effectively reduce the incidence of deviation protocol and im-prove the quality of drug clinical trials.关键词
药物临床试验/方案偏离/例数/类别/专职研究护士/国际多中心临床试验Key words
Drug clinical trial/Protocol deviation/Frequency/Category/Full-time research nurse/International multi-center clinical trial分类
医药卫生引用本文复制引用
刘金华,刘敏,刘雨村,段均,鲁毅..我院药物临床试验实施中方案偏离的回顾性研究[J].中国药房,2017,28(25):3474-3478,5.基金项目
重庆医科大学附属第一医院护理科研基金项目(No. HLJJ2014-08) （No. HLJJ2014-08）
