The evolution of legislation to regulate pediatric clinical trials: Present and continuing challenges

Advanced Drug Delivery Reviews
Kathleen R Gans-Brangs, Paul V Plourde

Abstract

Children suffer from many of the same diseases as adults and are often treated with the same agents. However, it was not until 1997 that legislation mandating studies in children was introduced in the United States. A 2000 International Conference on Harmonisation (ICH) Guidance on the Clinical Investigation of Medicinal Products in the Pediatric Population intended to encourage and facilitate timely pediatric clinical trials detailed critical issues in pediatric drug development and ways to ethically study the safety and efficacy of drugs in the unique and vulnerable pediatric population. In 2005, there is draft legislation in Europe. In Japan, pediatric data are not currently required although studies in pediatric populations are encouraged. This chapter describes the history of legislation on the study of drugs in the pediatric population and details present and continuing challenges for the child, parent/guardian, manufacturer and health authority.

References

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Aug 21, 2003·JAMA : the Journal of the American Medical Association·Rosemary RobertsTerrie Crescenzi
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Mar 31, 2010·Pediatrics·Robert E ShaddyUNKNOWN Committee on Drugs and Committee on Pediatric Research
Jul 16, 2014·Pediatrics·Gerold T WhartonEric L Eisenstein

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Citations

Jan 20, 2012·Expert Opinion on Drug Delivery·Alejandro SosnikDiego A Chiappetta
May 14, 2014·Advanced Drug Delivery Reviews·Alejandro Sosnik, Angel M Carcaboso
Jan 12, 2017·Paediatric Drugs·Gueorgui DubrocqB Ryan Phelps
Nov 26, 2008·Paediatrics & Child Health·Marie-Claude Grégoire, G Allen Finley

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