Conducting Clinical Trials in Developing and Emerging Countries: Review and Case Study

This chapter focuses on the trends, benefits, challenges and ethical considerations involved in the globalization of pediatric clinical trials and, more specifically, the conduct of these trials in developing countries. These considerations are discussed in the context of our experience with a multi-national drug trial-case study: The CLARINET Trial. The case study highlights some of the obstacles and benefits associated with this multi-national trial. With the added constraints associated with economic hardship, language barriers and limited education, there is potential for exploitation. The National Bioethics Advisory Commission established a series of recommendations to ensure the ethical conduct of clinical trials in developing nations. If attention and resources are allocated to develop global clinical trial infrastructure, then future clinical trials can be conducted more efficiently and effectively, with the potential to improve global child health significantly.

Duke Scholars

Author Kevin Dennis Hill Pediatrics, Cardiology

Author Jennifer Shiunroh Li Pediatrics, Cardiology