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Clinical Trials Offshored: On Private Sector Science and Public Health

Published online by Cambridge University Press:  01 March 2007

Adriana Petryna
Adriana Petryna
Affiliation:
Department of Anthropology, University of Pennsylvania, University Museum 334, PA 19104, USA E-mail: petryna@sas.upenn.edu
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Abstract

This article addresses the offshoring of clinical trials to middle- and low-income countries, and the complicated ways in which they have become integral to public health and quality of care in these contexts. I focus on the operations of United States-based contract research organizations (CROs), which make up a specialized global industry focusing on the recruitment of human subjects and investigators; they are key players in an outsourced world of clinical development ‘service providers’. To get an on-the-ground understanding of the offshored clinical trial, I worked with regulators, health services administrators, and research clinicians in Eastern Europe and Latin America, two clinical trial market ‘growth regions’. By addressing the strategies of evidence-making that inform clinical trial offshoring, this article identifies the context-specific calculations by which experimental groups are being identified. It also addresses aspects of the clinical trial operational model, in which the failure to predict safety outcomes or a paradigm of expected failure is being exported along with the offshored trial. By highlighting the uncertainties of clinical research, this article points to gaps in systems of human protection as it considers new forms of accountability in private sector science and public health.

Keywords

global pharmaceuticalsclinical trial environmentsoffshoringethical variabilityhuman subjectsresearch ethics
Type
Articles
Information
BioSocieties , Volume 2 , Issue 1: Special Issue: The Construction and Governance of Randomised Controlled Trials , March 2007 , pp. 21 - 40
Copyright
Copyright © London School of Economics and Political Science 2007

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