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No population left behind: improving pediatric drug safety using informatics and systems biology
  • Nicholas Giangreco,
  • Jonathan Elias,
  • Nicholas P. Tatonetti
Nicholas Giangreco
Columbia University
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Jonathan Elias
NewYork-Presbyterian/Columbia University Medical Center
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Nicholas P. Tatonetti
Columbia University
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Peer review status:IN REVISION

23 Apr 2020Submitted to British Journal of Clinical Pharmacology
24 Apr 2020Assigned to Editor
24 Apr 2020Submission Checks Completed
25 Apr 2020Reviewer(s) Assigned
27 Jul 2020Review(s) Completed, Editorial Evaluation Pending
02 Aug 2020Editorial Decision: Revise Major

Abstract

The current drug safety landscape inadequately serves the millions of children prescribed medications every year. Randomized clinical trials are limited in detecting pediatric adverse drug effects due to low participant enrollment, complicated study design, and short trial duration. While the biology of human development and the pathology of childhood diseases are well studied research topics, current pharmacoepidemiology approaches do not use this knowledge when investigating drug safety in children. Here, we describe how adverse drug effects manifest as children develop from birth through the teenage years. We discuss the benefits of an empirical approach for evaluating clinical relevance and biological causality of identified adverse drug effects in children. We argue that a data-driven strategy that leverages observational data and biomedical knowledge is an ethical and effective methodology to improve pediatric drug safety.