Drug News
Only 2% of pediatric drug trials have independent safety checks
By Sue Mueller
Mar 18, 2008 - 1:44:34 PM

TUESDAY March 18, 2008 (Foodconsumer.org) -- A new study published on March 18 in the journal Acta Paediatrica showed that only as few as 2 percent of pediatric drug trials used independent safety monitoring committees to detect adverse drug reactions early.

The review by researchers from the University of Nottingham involved 739 international drug trials published between 1996 and 2002 was meant to examine what safety measures were employed to monitor levels of adverse drug reactions.

As many as 74 percent of the drug trials described how safety monitoring was conducted during the study, but only two percent or 13 studies out of 739 actually had independent safety monitoring committees.

Dr Helen Sammons, lead author of the study, Associate Professor of Child Health in the University's Academic Division of Child Health, based at Derbyshire Children's Hospital, said: "We were very surprised by the low level of trials that had independent safety monitoring committees and are urging pharmaceutical companies to include these in all future trials involving children.

"It is essential that drugs are developed for use in children and clinical trials need to continue. They are vital because they increase the chance of picking up adverse reactions before drugs are introduced into general clinical practice."

The review also led to the following discoveries:

•     Seven out of ten trials reported adverse events and a fifth of the trials reported a serious adverse event, ie, an untoward medical occurrence, not necessarily related to a drug.

•     Adverse drug reactions were reported in just fewer than 37 percent of trials, with 11 per cent of trials reporting moderate or severe adverse drug reactions.

•     Six clinical trials - which all had safety monitoring committees - were terminated early because of significant drug toxicity.

•     Deaths were reported in 11 per cent of the trials, but the majority were thought to be unrelated to the drug use.

•     Death rates were highest in trials involving newborn babies, with 56 per cent of the 99 trials included reporting a death.

•     Other major specialities in which deaths were reported included infectious diseases, neurology, respiratory and kidney problems.

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

Among the studies, over half compared a drug with a placebo, 35 percent involved a new medicine and 26 percent compared two established drugs.  Some trials included both adults and children.

Studies on drug toxicity came from 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 covered included bleeding, high blood pressure, seizures, psychosis, suicide, acute renal failure and death.

Dr. Sammons and team stress that clinical drug trials in children are important for the development of medicines and to provide evidence of the best treatments for specific conditions. But greater safety measures and awareness of the risk is critical.

"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 license," said 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."

"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."

Adapted from a news release by http://www.nottingham.ac.uk/