Speculations and Ethical Concerns in the Conduct of Outsourced Clinical Trials in India

From The Embassy of Good Science
Cases

Speculations and Ethical Concerns in the Conduct of Outsourced Clinical Trials in India

What is this about?

This is a factual case about a study in which the various stakeholders of outsourcing clinical trials in India are interviewed. The study nuances the image sketched by the media about the size and the monetary worth of the practice of clinical trail outsourcing in India. In addition, the author raises the concern that the largest portion of India’s population does not benefit from the types of drugs tested in the outsourced clinical trials.

Why is this important?

When outsourcing clinical trials from the West to countries with an upcoming economy, such as India, we must remain cautious whether the same ethical standards are used as with a regular clinical trial. However, we should not judge this process on account of single cases or merely on media coverage. This study may give insight in the different perspectives of the stakeholders in the process of outsourcing clinical trials. Moreover, the study raises the question whether it is morally defensible to conduct clinical trials in countries whose population probably does not benefit from the drug under investigation. The declaration of Helsinki articulates that “medical research involving a disadvantaged or vulnerable population or community is only justified if the research is responsive to the health needs and priorities of this population or community”, suggesting that these clinical trials are not justifiable.[1] Therefore, as the author of the study suggests, more research into this topic is needed to determine the ethical implications of the outsourcing of clinical trials from the West to developing countries.

  1. Association, W. M. (2000). Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects. 52 Nd WMA General Assembly, Edinburgh, Scotland. http://ci.nii.ac.jp/naid/10011535346/en/

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