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Paediatric Drug Development and Clinical Trials

  • E. David G. McIntosh
Chapter
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 634)

Introduction

Children have featured in clinical research for a number of centuries, albeit in a relatively unregulated way. Edward Jenner utilized children in his work on smallpox in the late 1700s. Joseph Lister (1827–1912) utilized children in his work on wound infections and Louis Pasteur first tried his rabies vaccine, in 1885, on a child bitten by a rabid dog (Barfield and Church, 2005). In the early twentieth century, children at the Hebrew Orphan Asylum were fed diets known to induce scurvy and rickets so that these diseases could be better understood. Between 1958 and 1960, residents with learning difficulties at Willowbrook State School were deliberately exposed to hepatitis. European children had to wait until the beginning of the twenty-first century for their right to participate in clinical research to be enshrined in legislation.

The ‘New’ European Paediatric Legislation

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of December 12, 2006 on...

Keywords

Medicinal Product Orphan Medicinal Product Market Exclusivity Paediatric Clinical Trial Cash Inflow 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Barfield RC, Church C. Informed consent in pediatric clinical trials. Current Opinion in Pediatrics 2005; 17: 20–24.PubMedCrossRefGoogle Scholar
  2. Li et al. Economic return of clinical trials performed under the pediatric exclusivity program. JAMA 2007; 297: 480–488.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  1. 1.Wyeth Europa LimitedMaidenheadUK

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