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Only 2 percent of child drug trials have independent safety checks
Date:3/18/2008

p>Parents also need to be made aware of the risks of adverse drug reactions when a child takes any medicine so that they can make informed decisions that balance those risks against the possible benefits the drug may provide their child.

In a drug trial this should include information on the mechanisms that will be used during the clinical trial to safeguard the children taking part.

Dr Sammons points out that the number of paediatric drug trials is likely to rise in the European Union, following new legislation that provides pharmaceutical 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.

She added: 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 out in a way that minimises risks, and maximises benefits, for the children taking part.


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Contact: Dr. Helen Sammons
helen.sammons@nottingham.ac.uk
University of Nottingham
Source:Eurekalert

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