论文部分内容阅读
目的:对近5年我院新药临床试验项目质量检查情况进行总结以及对影响质量的因素进行分析。方法:收集120项新药临床试验项目质控结果,并对有质控报告的115项目按照问题严重程度进行了统计,计数资料采用χ2检验。结果:115项目出现严重问题项目6(5.2%)项,重要问题项目92(80.0%)项,一般问题项目17(14.8%)项。针对影响质量的不同因素进行了分析。结论:新药临床试验质量问题仍普遍存在,经验多的科室、有研究护士/临床研究协调员参与的临床试验项目质量较好。
OBJECTIVE: To summarize the quality inspection of clinical trials of new drugs in our hospital in the recent 5 years and to analyze the factors that affect quality. Methods: The quality control results of 120 clinical trial projects were collected, and 115 projects with quality control reports were counted according to the severity of the problems. The count data were analyzed by χ2 test. Results: There were 6 items (5.2%) of serious problems in 115 items, 92 items (80.0%) of critical items and 17 items (14.8%) of general issues. Different factors affecting the quality were analyzed. Conclusion: The quality of clinical trials of new drugs is still widespread. Clinical trials with more experienced departments and research nurses / clinical research coordinators have better quality.