Số lượng và chất lượng báo cáo các biến cố bất lợi nghiêm trọng trong các thử nghiệm lâm sàng tiến hành tại Việt nam từ 2006-2013

Objective: Analyse and describe reports of serious adverse events (SAEs) which were sent to Vietnam Ministry of Health in clinical trials conducted in Vietnam from 2006 to the end 2013, with a view to suggesting some approaches to improve the quality of reporting SAEs. Materials and research methods: A crosssectional study was used to analyze SAEs reports which were submitted to Vietnam Ministry of Health from 2006 to the end 2013. Results: Of 185 clinical trials, there were 189 SAEs reports sent to Ministry of Health. Median of submitting time is 13 days. Complete SEAs reports accounted for 82.01 percent. Systemic antibacterial drug group was most reported, with the largest reporting percentage 39.68 percent. The proportion of studies which were suggested to be continued performing is 73.54 percent.