Globalization of pediatric research: pharmacological RCTs in Latin America
Tóm tắt
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.
Tài liệu tham khảo
Kern SE. Challenges in conducting clinical trials in children: approaches for improving performance. Expert Rev Clin Pharmacol. 2009;2:609–17.
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;130:285–92.
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.
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):816–23.
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.
Benedetti V, Echeverria G, Riquelme I. Biomedical research in Latin America: we can do more. Lancet. 2016;387:941.
Joseph PD, Caldwell PH, Tong A, Hanson CS, Craig JC. Stakeholder views of clinical trials in low- and middle-income countries: a systematic review. Pediatrics. 2016;137(2):e20152800.
Dunne J, Murphy MD, Rodriguez WJ. The globalization of pediatric clinical trials. Pediatrics. 2012;130:e1583–91.
Homedes N, Ugalde A. Availability and affordability of new medicines in Latin American countries where pivotal clinical trials were conducted. Bull World Health Organ. 2015;93:674–83.
Duke T, Fuller D. Randomised controlled trials in child health in developing countries: trends and lessons over 11 years. Arch Dis Child. 2014;99:615–20.