Ethical variability: Drug development and globalizing clinical trials

Abstract

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.