Few drug companies are willing to undertake clinical trials in children voluntarily, according to a survey carried out by Britain's Consumers' Association. A change in the regulations governing drug licences may be the only option for ensuring that products used in children are safe and effective.
As part of its campaign to ensure that all drugs used in children are subject to the same regulatory procedures as those used in adults, the association wrote to all 79 members of the Association of the British Pharmaceutical Industry on 11 April asking them how they were addressing the issue. By the time the BMJ went to press earlier this week, only four companies had responded.
The low level of response suggests a general apathy in this area among the pharmaceutical industry, said a spokeswoman for the Consumers' Association.
“The pharmaceutical industry has a major contribution to make, and we are appalled at the level of response,” said Louise Ansari, the association's press officer. “However, it is heartening to see that some companies are approaching the issue responsibly. Norgine Limited, Bristol-Myers Squibb, and Schering Plough have all recently completed trials in children or are in the process of conducting them.”
Altogether 40% of drugs used to treat children are not licensed for that purpose, and a recent study found that across five European countries 67% of children in hospital receive unlicensed or “off label” drugs (8 January, pp 79-82).
Obtaining parental consent for sick children to enter a clinical trial can severely hamper progress, according to the companies who responded to the association's letter. They called for a financial incentive to be made available to them and quoted the scheme offered by the US Food and Drug Administration, which involves a six month extension to the drug patent.
Dr Ike Iheanacho, deputy editor of the Drug and Therapeutics Bulletin, dismissed the excuse of unwilling parents as “not necessarily true.” “Parents need to be told the facts and encouraged to take part in trials so that we can gather more data on children—otherwise we will always be in the dark,” he said.
Although an incentive scheme may encourage some companies to take action on licensing medicines for children it would always be voluntary and only presents an interim solution, said Dr Iheanacho. “Ultimately we would be arguing for some regulatory framework that requires all products destined for use in children to undergo rigorous trials,” he added.