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

Only papers published in English on the Medline database during the seven-year study period were included and the authors excluded studies that covered HIV and cancer because of high deaths rates from the actual diseases.

More than half of the studies (54 per cent) compared a drug with a placebo (dummy) and a further third (35 per cent) involved a new medicine. A smaller percentage (26 per cent) involved a direct comparison between two established drugs. Some of the trials included adults as well as children.

Studies reporting severe drug toxicity problems came from a wide range of countries, including Argentina, Belgium, Canada, Chile, China, France, India, Israel, Italy, Japan, Netherlands, South Africa, Sweden, Taiwan, Thailand, Turkey, UK and the USA.

Adverse drug reactions included bleeding, high blood pressure, seizures, psychosis, suicide, acute renal failure and death.

The researchers stress that clinical drug trials in children are essential for the development of medicines and to provide evidence of the best treatments for specific conditions. But they feel that greater safety measures and awareness of the risk is essential.

“We need to test drugs on children as the only other options are to use unlicensed drugs or prescribe drugs that have been licensed for adults off label - outside the terms of their licence” says Dr Sammons.

“But we feel that the small number of studies that reported having safety monitoring committees was unacceptable. It is invaluable to have an independent monitor who can swiftly question any adverse drug reactions or differences in illness and death rates between groups taking part in the clinical trials.

“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.”