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Implementing Clinical Research in Vietnam: A Dialogue on the Current Regulations of the Ministry of Health

July 2007 — A two-day workshop was held in Hanoi in which representatives from the Ministry of Health presented government regulations and procedures for conducting clinical research in Vietnam. Attending this workshop were approximately 60 medical professionals from institutions in Vietnam who participated as representatives from sites conducting international multicenter clinical research.

Since internationally sponsored clinical trials are relatively new in Vietnam and the appropriate processes have not always been clear to investigators and medical centers, the purpose of the workshop was to clarify these procedures and open a dialogue between the Ministry of Health and clinical research sites.

FHI 360 has worked for over 10 years in Vietnam in the fields of reproductive health, HIV/AIDS, and clinical research in numerous infectious disease areas. FHI 360's clinical research team has expanded within the past two years and now includes capacity building to clinical site staff on research ethics and Good Clinical Practice (GCP). Other training has been provided, including protocol implementation, regulatory management and many other aspects of clinical trials operations.