When Experiments Travel: Clinical Trials and the Global Search for Human Subjects Adriana Petryna, Princeton University Press, 2009

Abstract

The author sets the scene for the examination of global drug trial development by looking at the ways in which clinical trial evidence is constituted and experimental subjects are identified. ‘Treatment saturation’, characterised by a shrinking pool of available human subjects in the West for the pharmaceutical industry, an increasing demand both for new markets and for human research subjects in general, are identified as factors in the offshoring of clinical trials. Petryna shows how in the last 20 years the sites of research have shifted from academic to contract research organisations (CROs), which are typically subcontracted by pharmaceutical sponsors to collect the evidence required for drug approval by the FDA (Federal Drug Agency in the USA) or the EMEA (the European Agency for the Evaluation of Medical Products). Such CROs are competitive trans-national businesses that run trials not only for the pharmaceutical industry but also for bio-technological products and medical devices. Their projected growth is faster than that of the pharma industry. Responsible for locating research sites, patients, local experts and ethical review boards and on occasions for drawing up study design and performing analyses, the CROs may work with primary healthcare facilities such as hospitals and consortia of medical specialists. Some even have centralised institutional review boards to review protocols and subject recruitment to ensure the safety of trial volunteers. Alongside more permissive national legislative environments, factors such as population disease profiles, mortality rates, patient trial costs and potential for future marketing of the drug to be approved are essential in identifying new clinical trial sites. Petryna’s analysis illustrates how regulatory requirements, both in terms of patient safety and standardised scientific protocols, are made sense of by local actors in different ways. The offshoring of clinical trials equally needs to produce convincing scientific evidence for each drug’s adoption and various strategies are presented by clinical trial