A review published in Acta Paediatrica has found that from 1996 to 2002 only 2 percent of 739 children drug trials had independent safety monitoring. Independent safety monitoring gives an unbiased review of the drugs side affects and can determine if a drug trial should be stopped due to unwanted and harmful results. This is particularly important in children as they are more prone to issues than adults and could live with harmful effects for the rest of their lives.

When I read this earlier today I was shocked. I had always believed that compared to adult trials, children drug trials had higher standards and more emphasis on safety, however this report strongly shows my ignorance. The lead author Dr. Helen Sammons commented that “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.” Some surprising statistics come out of this report:

·     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 under 37 per cent 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.

It should be noted that almost three fourths of the trials had safety monitoring but were not independent and could be considered unreliable. Finally it should be mentioned that in many respects these type of trials are needed if children’s health and conditions are to ever improve but it should be done in a manner that is responsible.