Just 2% of child drug trials included independent safety checks says review of over 700 studies

Dr Sammons points out that the number of paediatric drug trials is likely to rise in the European Union, following new legislation that provides companies with a valuable financial incentive - a six-month extension to their exclusive manufacturing licence for a drug if children are included in the clinical trials. Similar legislation has been in place in the USA for over five years and has led to an increase in drug trials that include children.

“There is general agreement by paediatric health professionals, regulatory authorities and the pharmaceutical industry, as well as politicians and parents, that drug trials are essential in order to improve drug therapies.

“We are calling for all paediatric drug trials to include independent safety monitoring committees to ensure that this vital work is carried in a way that minimises risks, and maximises benefits, for the children taking part.”

Notes to editors

• Safety in paediatric clinical trials – a 7 year review. Sammons et al. Acta Paediatrica volume 97.4, 474-477 (April 2008).
• Acta Paediatrica is a peer-reviewed monthly journal at the forefront of international pediatric research. It covers both clinical and experimental research in all areas of pediatrics including: neonatal medicine, developmental medicine, adolescent medicine, child health and environment, psychosomatic pediatrics, child health in developing countries. It is published by Blackwell Publishing Ltd, part of the international Blackwell Publishing group. www.ActaPaediatrica.com
• About Wiley-Blackwell. Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley’s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit www.blackwellpublishing.com or http://interscience.wiley.com