The outsourcing and offshoring of clinical trials have sparked an unprecedented field of experimental activity. This essay addresses the scientific and regulatory mechanisms by which a global field of experimentality takes form. It charts a clinical trials industry and its move to low- and middle-income countries (particularly in Eastern Europe and Brazil). As the clinical trials enterprise adapts itself to international and national regulatory norms, the acknowledgement of adverse risks to patients and populations is often deferred or engineered out. The essay explores policy gaps with respect to how benefits and liabilities of this enterprise are weighed as well as emergent practices of accountability.
bioethics; clinical trials; global pharmaceuticals; research ethics