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American Pediatric Society
October 2015

Global Collaboration to Develop New and Existing Drugs for Neonates

Author Affiliations
  • 1Department of Pediatrics, Floating Hospital for Children, Tufts Medical Center, Boston, Massachusetts
  • 2Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts
  • 3Institute of Translational Medicine, Department of Women's and Children's Health, University of Liverpool, Liverpool, England
JAMA Pediatr. 2015;169(10):887-888. doi:10.1001/jamapediatrics.2015.1640

Neonates do not have access to medicines that have been adequately tested for dosing, safety, and efficacy.1 Physicians must use their best judgment to make up for these knowledge gaps, leading to incorrect, and possibly harmful, doses of unnecessary and expensive medications. Some experts even believe that it is difficult or unethical for research to be conducted in neonates.2 Neither of these beliefs are justified, and it is inappropriate to expose neonates to potential risk without conclusive evidence that the drugs they are receiving are safe and efficacious. Neonates must participate in all stages of drug development in trials that use contemporary methods, because the health care industry has an ethical duty to meet the needs of this population.3

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