Paediatric Drug Development and Clinical Trials
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...