Vaccinology Theme, Medical Research Council Unit, Banjul, The Gambia.
Am J Trop Med Hyg. 2013 Mar;88(3):414-9. doi: 10.4269/ajtmh.12-0576.
Immunization remains the most cost effective method for the control of infectious diseases. Therefore, there is a global effort to deploy new vaccines for disease control and eradication. These new vaccines must be tested in the settings in which they will be used. This necessity has required the conduct of many vaccine trials in Africa, where several infectious diseases with significant public health impact are prevalent. However, these areas have peculiarities and are just beginning to gain expertise in the conduct of such trials. The vaccine developers and sponsors of these trials may also not be conversant with some issues unique to the trial site. The understanding gap from both partners can result in challenges if not addressed during the planning phase of the trial. This review seeks to highlight the issues surrounding the conduct of clinical trials in resource-constrained settings and suggests some ways of circumventing them.
免疫接种仍然是控制传染病的最具成本效益的方法。因此,全球正在努力部署新的疫苗来控制和消灭疾病。这些新疫苗必须在将要使用的环境中进行测试。这一必要性要求在非洲进行许多疫苗试验,因为那里有几种具有重大公共卫生影响的传染病流行。然而,这些地区具有特殊性,刚刚开始在进行此类试验方面获得专业知识。这些试验的疫苗开发商和赞助商也可能不熟悉试验现场特有的一些问题。如果在试验规划阶段不解决这两个合作伙伴之间的理解差距,可能会导致挑战。本综述旨在强调在资源有限的环境中进行临床试验所面临的问题,并提出一些解决方法。