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Review
. 2019 Mar 4;45(1):29.
doi: 10.1186/s13052-019-0622-1.

Globalization of pediatric research: pharmacological RCTs in Latin America

Federica Arienti  1   2 , Claudia Pansieri  3 , Chiara Pandolfini  1 , Andrea Biondi  2 , Maurizio Bonati  1
Affiliations
Review

Globalization of pediatric research: pharmacological RCTs in Latin America

Federica Arienti et al. Ital J Pediatr. .

Abstract

Globalization caused a shift in trial locations towards low-middle income countries, raising ethical concerns. These include the risk that conditions primarily affecting children in these countries will be neglected in favor of those affecting developed countries. We analyzed 253 published and 69 ongoing pharmacological RCTs performed in Latin America between 2000 and 2015 involving exclusively children. While over 50% of the previously highly investigated diseases were no longer priorities, other diseases acquired greater attention in recent years. Brazil and Mexico resulted as the most active countries. A large gap remains between the real needs of children in these countries and scientific research.

Keywords: Developing countries; Globalization; Latin America; Randomized clinical trials.

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“The authors declare that they have no competing interests”.

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References

    1. Kern SE. Challenges in conducting clinical trials in children: approaches for improving performance. Expert Rev Clin Pharmacol. 2009;2:609–617. doi: 10.1586/ecp.09.40. - DOI - PMC - PubMed
    1. Bourgeois FT, Murthy S, Pinto C, Olson KL, Ioannidis JP, Mandl KD. Pediatric versus adult drug trials for conditions with high pediatric disease burden. Pediatrics. 2012;130:285–292. doi: 10.1542/peds.2012-0139. - DOI - PMC - PubMed
    1. Ward RM, Benjamin DK, Jr, Davis JM, Gorman RL, Kauffman R, Kearns GL, et al. The need for pediatric drug. Development. 2018;192:13–21. - PMC - PubMed
    1. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816–823. doi: 10.1056/NEJMsb0803929. - DOI - PubMed
    1. Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743–800. - PMC - PubMed

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