Đánh giá một số yếu tố ảnh hưởng tới hoạt động báo cáo biến cố bất lợi nghiêm trọng (SAE) trong thử nghiệm lâm sàng thuốc tại Việt Nam

Monitoring and reporting of serious adverse events (SAE) is the most important activity of good clinical practice and research ethics in Clinical trials (CT) to ensure the safety of participants and the quality of research. However, the lack of information in SAE reporting still occurs in many clinical trial studies worldwide. The aimed of this research is to (i) Identify factors affecting SAE reporting activities in Clinical trials of drugs and (ii) Evaluate the level of influence of each factor on SAE reporting activities in Clinical trials of drugs in Vietnam. The findings indicated that there are 05 main factors impacting on SAE reporting in Vietnam arranged in the level of influence on SAE reporting activities as follows: (1) Regulations and reporting procedures (Beta: 0.438); (2) Reporting form and submission method (Beta: 0.420); (3) Knowledge and attitude of investigators (beta: 0.266); (4) Patients participate in clinical trials (Beta: 0.104); (5) Other factors. Regulations and reporting procedures (Beta: 0.438) were the most influent factor in SAE reporting activities. Health authority should have priority solutions to improve the quality of SAE reporting activities in Vietnam. It is necessary to improve SAE reporting regulations and procedures, to develop report review and feedback mechanism, to modify reporting form, to develop and implement online reporting systems, to provide intensive training on safety reporting in clinical trial to investigators.
Keywords: Serious adverse events (SAE): Clinical trials (CT).