Clinical Site Development and Preparation for AIDS Vaccine Efficacy Trials in Developing Countries
Patricia E. Fast, Jean-Louis Excler, Mitchell Warren and Nzeera Ketter
from: AIDS Vaccine Development: Challenges and Opportunities (Edited by: Wayne Koff, Patricia Kahn and Ian D. Gust). Caister Academic Press, U.K. (2007)
Abstract
Experience over the past decade shows that high-quality AIDS prevention trials can be successfully conducted in resource-poor settings. For example, Thailand successfully conducted the world's second AIDS vaccine trial, and in 2003 launched another one, while a smaller (proof-of-concept) efficacy study is ongoing in non-industrialized countries, In addition, nearly a dozen developing countries have cumulatively helped carry out over 20 Phase I and II studies. However, preparation for clinical trials in research-poor settings requires significant investment in infrastructure, equipment, training and health care for local communities. It also entails creating an "enabling environment" by building political support and partnerships with community organizations, engaging the media to reach out to the community-at-large, and (in some countries) clarifying regulatory pathways. Most of all, trials require a committed team of effective local scientists and staff and (particularly in the initial phases) experienced clinical trials professionals. More capacity for clinical trials of HIV vaccines and other prevention methods is still needed in resource-poor settings hit hard by the AIDS epidemic. The time to build this capacity is now read more ...
