Global outsourcing continues, and fuels some interesting debate, as evidenced by this recent New England Journal of Medicine (NEJM) article, "Ethical and Scientific Implications of the Globalization of Clinical Research." Of current interest, one of the author's name, Robert Califf, comes up as a candidate to lead the FDA.
In CenterWatch's Clinicial Trials Today post, "Duke, NEJM Study Renews Debate on Global Outsourcing, they say "the NEJM study findings support common criticisms that trial participants in developing countries are often less informed and unduly influenced by the promise of money or medical care in return for participating in a study. While critics of clinical research in emerging areas (comprising 16% of total global clinical trials) can deride the informed consent process there, the West is no stranger to these problems."
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Friday, February 27, 2009
Global Outsourcing - Clinical Drug Trials - Hot Debate
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Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
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2 comments:
Thanks for this useful post..........
Thanks for this great post......
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