Fast, cheap, and out of control? Speculations and ethical concerns in the conduct of outsourced clinical trials in India

Abstract

The globalization of biopharmaceutical clinical trials and their offshore outsourcing, from the West to low and middle-income countries, has come under increasing scrutiny from academic scholars, practitioners, regulatory agencies and the media. This article reports the results of a study conducted in Bangalore and Hyderabad between 2007 and 2009, to elicit the perspectives of stakeholders, concerning media representations of their work and the ethical issues that emanate from their engagement in the clinical trials enterprise. In acknowledging the inherently problematic nature of the outsourcing of clinical trials to low income countries, I argue that the practice of not prioritizing research on diseases that are most prevalent among communities, from which subjects are recruited, demands a coordinated and sustained critique. I propose that the critical discourse on the outsourcing of clinical trials should not only emphasize the perils of this practice, but also address some broader issues of equity and distributive justice that determine people's access to basic health care in low income countries. Close attention to the specific context of clinical trials in an increasingly neoliberal medical and health environment in emerging economies such as India can provide critical insights into the on-the-ground complexities and challenges of outsourced global clinical trials.