Evaluation of capacity to conduct phase 3 vaccine clinical trials of provinces in central and southern Vietnam

Abstract

A descriptive study utilizing a predesigned survey questionnaire based on both Vietnamese and international regulations on Good Clinical Practice (GCP) was conducted. The survey covered four unit infrastructure, human resources, the ability to recruit potential participants, and the capability to use online applications for data collection in research at four potential provinces, including Obstetrics and Paediatrics Hospital in Quang Nam, Kien Giang; Provincial General Hospital in Dong Thap, Cai Lay General Hospital in Tien Giang. Regarding infrastructure, all units met a safety requirement for vaccination points, clinical areas, research product storage areas, specimen storage areas, and document storage areas. However, there was a need for improvements and additions to specialized equipment. Three out of the four surveyed units had sufficient infrastructure to participate in phase 3 clinical vaccine trials. There was the data source of potential participants at Health Centers and school. The implementation of real time applications for entering, reporting study data by study participants is feasible. The annual survey of the capability to conduct phase 3 clinical vaccine trials at potential sites is necessary to immediately respond to requests from vaccine clinical trial sponsors.