Support for Clinical Trials in Developing Countries in the area of Good Clinical Practice (GCP) and Bioethics
As the vaccine research wing of WHO, IVR strengthens the capacity of selected clinical trial sites in developing countries to conduct vaccine studies with adherence to GCP guidelines and bioethical review standards. The strategic partner for these activities is the UNICEF/UNDP/ World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR). In addition, the WHO Research Ethics Review Committee (ERC), is responsible for reviewing the ethical aspects of WHO supported research proposals involving human participants. This ensures that WHO supported research is conducted in an ethical manner which respects the rights of research participants and recognizes the responsibilities of researchers. This includes:
- research that is fully or partially funded by WHO;
- research that is managed by WHO;
- research in which WHO is either a partner or a collaborator.
Guidelines, checklists and templates useful for researchers in this process can be accessed here.
As trial sponsor, IVR implemented the site assessment, and prepared and initiated the Phase II open label safety, immunogenicity and reactogenicity trial of Mencevax ACW135 polysaccharide vaccine in Ethiopia. Preparatory activities were also carried out for the measles aerosol vaccine clinical trials in India and Mexico. In addition, activities related to capacity building for GCP implementation were conducted for projects on pneumococcal, malaria and Japanese encephalitis candidate vaccines in a number of countries.
For the core GCP training, a curriculum for workshops focusing on vaccine clinical investigators was developed, and two workshops for HIV/AIDS and malaria vaccine investigators conducted in the United Republic of Tanzania and Thailand respectively, attended by more than 60 investigators from countries with high burden of the two diseases.
In response to requests from researchers, IVR is developing generic guidelines in the form of a core data set and standard definitions for the conduct of neonatal vaccine trials. These guidelines, produced with the Brighton Collaboration, will be available in mid 2006.