Researchers Slam EU Opt-out Rules for Pediatric Cancer Drug Trials

EU rules dating from 2007, allowing pharmaceutical companies to opt out of pediatric trials with new cancer medicines if the disease they are intended to treat rarely affects children, have come under fire in the UK.

"Many cancer drugs developed for adults could be effective in children if we were able to test them in clinical trials," said Louis Chesler, a researcher at Britain's Institute for Cancer Research (ICR) and a pediatric oncologist at London's Royal Marsden hospital.

Chesler said the current rules put children at risk. Of the 28 new cancer drugs approved in the EU for adults since 2007, about 28 could be potentially effective in children, he asserted, while noting that 14 of these have been exempted from clinical trials.

The ICR and allied campaigners are calling for the EU legislation to be revised, saying this could save or extend many young cancer patients' lives. The institute maintains that the current system "causes long delays before new life-saving drugs become available for children as well as results in crucial drugs not getting licensed for pediatric use."

The researchers say around 1,600 children are diagnosed with cancer in the UK each year, and that doctors prescribe adult cancer drugs that have not been formally tested on children.

British news reports quote the National Institute for Health and Care Excellence, which sets guidelines for the National Health Services (NHS) as saying that all children and young people with cancer should be offered the opportunity to enter any clinical trial for which they are eligible, and adequate resources should be provided to support such trials.