Kagan Jonathan, Giang Dao Duc, Iademarco Michael F, Phung Van Tt, Lau Chuen-Yen, Quang Nguyen Ngo
National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Clinical Research, Bethesda, MD.
FH1 360, Clinical Research and Laboratory Science, Hanoi, Vietnam.
Public Health Rep. 2016 May-Jun;131(3):396-403. doi: 10.1177/003335491613100305.
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.
尽管改善卫生系统有望带来重要益处，但大多数发展中国家缺乏资源来支持由国家主导的临床研究。加强临床研究能力可通过支持在使研究与国家优先事项保持一致方面拥有更大自主权来推进国家卫生目标。2010年3月至6月，我们评估了越南临床研究能力的六个要素：研究议程；临床研究人员和生物统计学家；捐助者和赞助商；社区参与；科学、伦理、安全和质量监督；以及临床研究机构。评估来自对研究人员、卫生部工作人员、非政府组织和美国使团工作人员的访谈以及文件审查。观察结果和建议与合作者进行了分享。2015年的重新评估发现临床试验数量有所增加，在保护人类受试者和社区参与方面的监管有所改善，并且在研究议程设定方面取得了适度进展。对机构的培训和投资仍然具有挑战性。评估临床研究能力的框架可以明确优势和劣势，并指导能力建设工作的协调。
