5
Regulatory Issues
The Challenge: National regulatory oversight of clinical trials is the cornerstone of safe and scientifically valid medical research. However, many developing countries lack expertise and well-defined processes for reviewing and approving clinical trials and assessing results—a critical roadblock for HIV vaccine research, given that many trials will need to be conducted in developing countries.
“ Our generation will be judged by its success or failure in making a vaccine and ensuring equitable access to it. ”
—Malegapuru William Makgoba,
Vice-Chancellor & Principal,
University of KwaZulu-Natal, South Africa
Recommendations: The Enterprise scientific plan calls for regulatory experts in industrialized and developing countries to share their experiences through training curricula and programs. Improving regulatory capacity would minimize bottlenecks in conducting clinical trials of HIV vaccine candidates, and accelerate licensing of vaccines that prove safe and effective.