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Journal of Postgraduate Medicine
Medknow Publications and Staff Society of Seth GS Medical College and KEM Hospital, Mumbai, India
ISSN: 0022-3859 EISSN: 0022-3859
Vol. 54, No. 4, 2008, pp. 318-323
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Bioline Code: jp08107
Full paper language: English
Document type: Symposium
Document available free of charge
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Journal of Postgraduate Medicine, Vol. 54, No. 4, 2008, pp. 318-323
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Clinical research in India: Great expectations?
Thatte, U.M. & Bavdekar, S.B.
Abstract
India is considered as a preferred site for conducting global clinical trials. Existence of a large treatment-naοve population, availability of English-speaking, skilled doctors, plenty of clinical material, and cost-savings are obvious advantages for carrying out clinical research in India. However, challenges exist at various levels. Lack of formal training in bioethics and research methodology, heavy burden of clinical duties and sub-optimal administrative support restrict investigators. Absence of oversight of functioning of ethics committees (ECs) and lack of mechanisms for ensuring quality of ethics review heighten societal concerns about safety of participants. Conducting research on issues not relevant to local needs and failure to ensure post-trial access further enhance society′s cynicism. These issues need to be tackled through capacity building, training of investigators and EC members, strengthening of EC functioning and encouraging greater community participation.
Keywords
Clinical trial, research ethics, bioethics
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