Ethics of Outsourcing Drug Trials

Ethics of Outsourcing Drug Trials

Somjit Barat
DOI: 10.4018/IJARPHM.2021070101
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Abstract

With rising costs of drug testing and more stringent requirements, Western countries have been increasingly outsourcing their drug trials. While such actions make sense from a cost-benefit point of view, can we conclude the same from a marketing-ethics perspective? Are these lesser-developed countries being held to the same ethical standards and practices as expected in the Western countries? Are the drug companies' actions somehow influencing the research participants' decision to partake in such trials? The author applies the theory of reasoned action and ethical marketing underpinnings to develop relevant propositions. Consequently, drug testing companies, research participants, and marketing agencies can utilize these propositions to investigate whether more rigorous oversight is required to protect research participants.
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2. Outsourcing Of Drug Trials

Western countries frequently outsource their drug trials to LDCs. According to a recent study (Eslami, 2020), more than forty percent of US clinical trials were conducted outside the US. The Office of Inspector General (OIG) noted in a 2010 report the increasing use of locations outside the Western world for clinical trials, and highlighted FDA statistics pertaining to the same (Levinson, 2010):

  • Over half of all clinical trial sites are outside the U.S.

  • 35% of non-U.S. clinical investigators were conducting trials under independent agencies.

  • 80% of applications for drugs and biologics contain data from ex-U.S. studies.

  • 78% of all research participants were enrolled outside the U.S.

  • 87% of all research participants in recent biologics trials were enrolled outside the U.S.

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