Capacity building in Good Clinical Practice and Bioethics
Before a new vaccine is introduced in a developing country, it should be tested in representative populations using relevant schedules and endpoints. Furthermore, some vaccines are only likely to be required “and hence evaluated for efficacy” in developing countries. All vaccine trials should meet Good Clinical Practice (GCP), and ethical and applicable regulatory requirements. However, most institutes and clinical sites located in developing countries with a high prevalence of diseases such as malaria, tuberculosis or AIDS, have no experience in GCP, nor the capacity to conduct good quality trials or ethical reviews. Capacity building for research institutes in developing countries to conduct such trials is therefore a priority.