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Article

1 Aug 2009

Author:
Sandhya Srinivasan, Himal [India]

Bodies for hire; The outsourcing of clinical trials [India]

As [clinical] trials shift to countries such as India, there has been an international debate on ethical concerns of the outsourcing boom. This debate has been partly responsible for amendments in the World Medical Association’s Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects”...Other than the boasts of CROs [Contract Research Organisations], there is little information available on the hundreds of clinical trials being conducted in India. This is despite the evidence that many of these trials are conducted for the benefit of international drug companies, at unacceptable cost to the local population; that trial subjects could be put at risk; that subjects often have not given their informed consent to participate; that they might be provided care that is of lower quality than if they had been recruited for a trial in the West; that injuries during a trial might not be investigated thoroughly, and that those injured may not receive treatment of the highest standard, or even compensation; and that drugs that are tested are often too expensive for people who need them in India. [refers to GVK Biotech, Wyeth Pharmaceuticals, Shire Human Genetic Therapies, Johnson & Johnson, Igate, Veeda, Spectrum Clinical Research, Quintiles]