Pediatrics Research Today is a free monthly online journal that collates and summarizes the latest research about Pediatrics, including details on child development, perinatal medicine, child health care.

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

Gans-Brangs KR, Plourde PV

AstraZeneca LP, 1800 Concord Pike, PO Box 15437, Wilmington, DE 19850-5437, USA. kathy.gans-brangs@astrazeneca.com

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.

Published 17 April 2006 in Adv Drug Deliv Rev, 58(1): 106-15.
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