NDLI: Paradigms of expected failure

Content Provider	Springer Nature Link
Author	Petryna, Adriana
Copyright Year	2009
Abstract	This study explores the outsourcing and offshoring of clinical trials and how they interconnect with the dynamics of drug development and regulation in the United States. I focus on the activities of United States-based contract research organizations, which make up a specialized global clinical trials industry focusing on the recruitment of human subjects and investigators. Tracking this industry’s activities in eastern Europe and Latin America, two clinical trial market ‘growth regions,’ I address the strategies of evidence-making that inform clinical trial offshoring. I also show how aspects of the clinical trial model—in which failures to predict safety outcomes or a paradigm of expected failure—are being exported along with the offshored trial. The clinical trials industry is a crucial, highly mobile, and profitable arm of the global pharmaceutical industry. Where state agencies furnish limited or no health care, drug developers claim that trial expansion and experiments have become social goods in themselves. But questions remain: How is drug value and research integrity maintained? And how do the results of clinical trials strengthen or undermine the delivery of affordable and effective interventions? As this essay shows, clinical trials are not only hypothesis-testing instruments; they are operative environments redistributing resources and occasioning tense medical and social fields. In highlighting the inefficiencies and uncertainties of global drug development, this study points to problems in the operational model of drug development and in systems of human protection. It also considers new forms of accountability at the nexus of private sector science and public health.
Starting Page	57
Ending Page	65
Page Count	9
File Format	PDF
ISSN	03044092
Journal	Dialectical Anthropology
Volume Number	34
Issue Number	1
e-ISSN	15730786
Language	English
Publisher	Springer Netherlands
Publisher Date	2009-08-27
Publisher Place	Dordrecht
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Clinical trials Offshoring Global pharmaceuticals Risk management Research ethics Public/private partnerships Anthropology
Content Type	Text
Resource Type	Article
Subject	Sociology and Political Science Arts and Humanities Anthropology

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
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