Abstract

This article addresses the expansion of clinical trials to the developing world as part of the globalization process. Driven initially by the need to reduce costs and the potential to access subject populations, the pharmaceutical enterprise has greatly expanded the number of clinical trials in low- and middle-income countries. As the number and complexity of clinical trials has grown, the challenges have become more apparent. Challenges include: poorly trained personnel, insufficient medical infrastructure, inadequate institutional review boards, lack of monitoring, conflicts of interest, and many ethical issues, especially protecting the rights of vulnerable populations during the informed consent process. High-income countries can also play a critical role in helping the developing world build their clinical research capacity. Such efforts offer the very real prospect of improving healthcare in the developing world.