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Equity and AccessHealth Care Studies in India$
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Purendra Prasad, Amar Jesani, and Sujata Patel

Print publication date: 2018

Print ISBN-13: 9780199482160

Published to Oxford Scholarship Online: July 2019

DOI: 10.1093/oso/9780199482160.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2019. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 21 November 2019

Structure, Organization, and Knowledge Production of Clinical Trial Industry

Structure, Organization, and Knowledge Production of Clinical Trial Industry

Chapter:
(p.178) 8 Structure, Organization, and Knowledge Production of Clinical Trial Industry
Source:
Equity and Access
Author(s):

Roger Jeffery

Gerard Porter

Salla Sariola

Amar Jesani

Deapica Ravindran

Publisher:
Oxford University Press
DOI:10.1093/oso/9780199482160.003.0009

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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