Structure, Organization, and Knowledge Production of Clinical Trial Industry
Structure, Organization, and Knowledge Production of Clinical Trial Industry
This chapter reviews the evidence about the scale and significance of clinical trials in India. After describing some of the new social forms that service these trials it assesses the growth in their number from 2005 to 2012 and the reasons for—and implications of—a decline since then. The main argument is that the nascent Indian clinical trials industry rapidly adjusted to the opportunities provided by reforms, linked to India’s accession to the TRIPs agreement and the World Trade Organization in 2005. By contrast, Indian regulators were slow to come to terms with the challenges of responding to well-co-ordinated trial sponsors and contract research organizations.
Keywords: Clinical trials, India, ethical review, regulation, global assemblages, contract research organizations
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