Ethical variability: Drug development and globalizing clinical trials

Authors


ABSTRACT

The rapid growth of pharmaceutical markets has led to increased demands for human subjects for drug research, particularly in low-income countries. For regulatory, economic, and even biological reasons, new populations are being pursued as human subjects for pharmaceutical trials. In this article I consider the evolution of commercialized clinical trials and ethical and regulatory environments as they contribute to a dramatic growth of human-subjects involvement in research. I focus on the operations of U.S.-based contract research organizations (CROs), which make up a specialized global industry focusing on human-subjects recruitment and research and the on ways in which they expedite drug testing to low-income contexts. Specifically, I analyze how these transstate actors interact with regulatory authorities in the United States and how they recast international ethical guidelines as they organize trials for research subjects abroad.

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