Ethical and scientific implications of the globalization of clinical research.

n engl j med 360;8 nejm.org february 19, 2009 816 Economic globalization is an important development of the past half century. Proponents of globalization highlight the benefits of greater economic growth and prosperity; critics point to the exacerbation of economic disparities and the exploitation of workers, particularly in developing (i.e., lowand middle-income) countries.1,2 Pharmaceutical and device companies have embraced globalization as a core component of their business models, especially in the realm of clinical trials. This phenomenon raises important questions about the economics and ethics of clinical research and the translation of trial results to clinical practice: Who benefits from the globalization of clinical trials? What is the potential for exploitation of research subjects? Are trial results accurate and valid, and can they be extrapolated to other settings? In this article, we discuss recent trends in and underlying reasons for the globalization of clinical research, highlight important scientific and ethical concerns, and propose steps for the harmonization of international clinical research.