Abstract
The article reviews the international clinical research projects that were conducted in Latin America prior to the surge in the globalization of clinical trials. It also explains the late interest of the pharmaceutical industry in outsourcing clinical trials in the region, and shows the institutional and regulatory adaptations that countries had to implement to accommodate those interests. The need for implementing the trials in accordance with protocol at appropriately equipped research sites and by qualified researchers, and in compliance with internationally accepted ethical standards is also discussed. Based on these discussions, the article analyzes whether clinical trials in Latin America have actually resulted in tangible benefits for its population.
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Notes
- 1.
If household income were to be used to determine poverty, demographers would undoubtedly point to the problems to be encountered, probably many insurmountable. There are other variables or combinations that could be used, such as occupation, household location, functional literacy, or level of formal education.
- 2.
Some might consider that the price of a product cannot be determined before the development process is completed. Consequently, a pharmaceutical company could not determine the price of an innovative drug before the clinical trials are concluded and the data analyzed. Contrary to this affirmation, it is possible for the pharmaceutical industry to estimate closely the cost of a clinical trial using the number of patients to be recruited, the number of sites, and the locations of the sites. Estimates of costs of trials are prepared when the pharmaceutical company contracts with a CRO to implement the trial.
Additionally, some CEOs have admitted that the price of a new drug is not related to the cost of research and development but to the price the buyer will be willing to pay. In many countries the buyer is the government, and in the United States also health insurance companies and pharmacy benefits managers. This is the reason why the price of the same drug is different in each country, and the differences can be extremely large.
That the price is not related to cost is also confirmed when the industry justifies high prices based on savings obtained in comparison to costs of alternative treatments; if a patient’s health deteriorates, the industry argues, medical costs are greater than the cost of the drug.
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Homedes, N., Ugalde, A. (2019). Outsourcing Clinical Trials to Latin America: Causes and Impact. In: Rivera-López, E., Hevia, M. (eds) Controversies in Latin American Bioethics. International Library of Ethics, Law, and the New Medicine, vol 79. Springer, Cham. https://doi.org/10.1007/978-3-030-17963-2_8
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