Wednesday, November 16, 2011

Delhi to examine 'weak regulation' of clinical trials -- The Independent


Margrete Auken, Danish Green Party MEP, said Europe must treat unethical clinical trials with the same gravity as organ trafficking and called for companies to be "named and shamed".

There are almost 120,000 clinical trials currently taking pace in 178 countries. But only 36 of those countries have effective drug regulators, including just one in Africa, one in Latin America and three in Asia. This means Western regulators, including the EMA and the US Food and Drug Administration, know that huge numbers of clinical trials are taking place without adequate supervision. The EMA has never rejected a new drug solely on the basis of ethical violations.

Posted via email from Jack's posterous

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