Managing International Clinical Trials

Catalog description

Focuses on initiating, collecting, and managing data from multicountry clinical trials. The assigned material documents the growing internationalization of clinical research in biomedicine. For example, even trials carried out under the aegis of the U.S. FDA are likely to involve investigators in the European Union, China, India, Africa, or Latin America. The global nature of this research is due to the advantages that certain countries offer, including lower costs, flexible health infrastructures, and the presence of treatment-naïve populations. Multisource studies, however, present their own practical, legal, and ethical challenges. Offers students an opportunity to study the steps needed to conduct regulatory-compliant international trials. Through case studies and group projects, examines strategies to integrate clinical sites along common protocols and deadlines.