Abstract
Clinical trials are an integral part of the development and improvement of pharmaceutical, medical device, and biotechnology products, but they are costly, risky, and difficult to execute. To seek relief from high costs, long drug development time lines, and recruitment obstacles, pharmaceutical companies have increasingly moved their clinical trials overseas. While doing so provides drug companies with advantages they cannot access in the United States, it also presents legal, regulatory, ethical, and cultural questions that are inherent in setting up and conducting a clinical trial in a foreign jurisdiction. This chapter presents an analysis of those questions, including the various legal landscapes with which clinical trial sponsors must contend, as well as practical considerations for sponsors and drug companies to consider. The chapter concludes with suggestions to mitigate the risks of preparing for and executing a transnational clinical trial.
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