title: Assessing Clinical Research Capacity in Vietnam: A Framework for Strengthening Capability for Clinical Trials in Developing Countries.
abstract: Although improving health systems promises important benefits, most developing nations lack the resources to support nationally driven clinical research. Strengthened clinical research capacity can advance national health goals by supporting greater autonomy in aligning research with national priorities. From March through June 2010, we assessed six elements of clinical research capacity in Vietnam: research agenda; clinical investigators and biostatisticians; donors and sponsors; community involvement; scientific, ethical, safety, and quality oversight; and clinical research institutions. Assessments were drawn from interviews with investigators, Ministry of Health staff members, nongovernment organizations, and U.S. Mission staff members, and document review. Observations and recommendations were shared with collaborators. Reassessment in 2015 found growth in the number of clinical trials, improved regulation in human subjects protection and community engagement, and modest advances in research agenda setting. Training and investment in institutions remain challenging. A framework for assessing clinical research capacity can affirm strengths and weaknesses and guide the coordination of capacity-building efforts.
authors.affiliation: National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Clinical Research, Bethesda, MD.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kagan
authors.affiliation: FH1 360, Clinical Research and Laboratory Science, Hanoi, Vietnam.
authors.forename: Dao Duc
authors.initials: DD
authors.lastname: Giang
authors.affiliation: Centers for Disease Control and Prevention, Office of Public Health Scientific Services, Center for Surveillance, Epidemiology and Laboratory Services, Atlanta, GA; Health Affairs Attaché Office, U.S. Mission, Hanoi, Vietnam.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Iademarco
authors.affiliation: Health Affairs Attaché Office, U.S. Mission, Hanoi, Vietnam.
authors.forename: Van Tt
authors.initials: VT
authors.lastname: Phung
authors.affiliation: National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Clinical Research, Collaborative Clinical Research Branch, Bethesda, MD.
authors.forename: Chuen-Yen
authors.initials: CY
authors.lastname: Lau
authors.affiliation: Vietnam Ministry of Health, Administration of Science Technology and Training, Hanoi, Vietnam.
authors.forename: Nguyen Ngo
authors.initials: NN
authors.lastname: Quang
mesh_terms: D035843:Biomedical Research / Q000191:economics; D057191:Capacity Building / Q000191:economics; D002986:Clinical Trials as Topic / Q000191:economics; D003906:Developing Countries; D006801:Humans; D014481:United States; D014744:Vietnam