The Institute for Cancer Research (ICR) in the UK is challenging current European regulations governing clinical trials in children, claiming that the out-of-date rules are limiting pediatric patients’ ability to access new cancer treatments.
Under the current EU Pediatric Regulations, which were established in 2007, drug companies can choose not to run clinical trials in children, even if there is sufficient evidence that the new cancer drugs could be beneficial to them. As such, in the last five years, the clinical trials for 33 out of 53 cancer treatments, which have ultimately been approved for use, have been run without pediatric patients.
The ICR, along with the Royal Marsden, a specialist cancer treatment facility in London, are now urging decision makers to revise these rules so that companies are required to include children in their clinical trials whenever there is evidence that they could benefit from the drugs. These groups have argued that until this change is made, children will be at risk of falling behind adult cancer patients when it comes to taking advantage of new drug developments.
Alongside this, the ICR is also pushing for more flexibility when it comes to the age restrictions for clinical trials. The group believes there could be a huge benefit in lowering the age limit for adult trials, so that adolescents can be included where clinically appropriate, and increasing the age limit for pediatric trials, so that young adults can be included, again, where deemed clinically appropriate.
Further still, there have also been calls for stronger economic incentives for companies developing treatments that could potentially benefit pediatric patients. Many cancers are much rarer in children than they are in adults which can make it harder for companies developing drugs for this patient population to recoup their investment. Economic incentives are, therefore, necessary to encourage companies to develop drugs for children.
Cancer experts have stressed the importance of ensuring that these changes are made and that they are applied across all of Europe, including the UK after the country leaves the EU.