European regulators are being lobbied by a cancer charity calling for reform of drug trial regulations for childhood cancer.
A letter, published by The Guardian in March 2017 and written in support of the Institute of Cancer Research, London, calls for the reform of European regulations surrounding clinical trials of childhood cancer treatments.
Children and young adults are not usually given the latest, most effective cancer treatments, and this is largely due to European regulations that are being described as outdated. Current EU legislation offers pharmaceutical companies a loophole that enables them to avoid carrying out clinical trials of cancer drugs for children.
Missing Out
The Institute of Cancer Research in London analysed data provided by the European Medicines Agency. The information suggests that 33 new drugs developed for the treatment of cancer since 2012 have been prevented from being trailed by children. This is despite clear evidence that many of these treatments could prove effective.
The problem appears to be down to the rare nature of childhood cancers, as companies receive very little incentive to work on finding effective drug treatments. Dramatic advances in treatments for adult cancer could benefit children if such regulatory loopholes did not exist.
Opportunities for Change
Considerably out-of-date regulations allow companies within the pharmaceuticals industry to sidestep paediatric trials if the cancer targeted is not one that occurs in childhood. However, the most recent scientific research suggests that it is not where the cancer appears but the cause on a genetic level that is the most important determining factor when it comes to developing treatments that work. Adaptive phase 1 clinical studies of childhood cancer drugs, such as those carried out at http://www.richmondpharmacology.com/adaptive-phase-i-studies.php, offer the chance for great strides to be made.
Inequality
Children are being denied a variety of different drug treatments that have the potential to effectively target their cancer’s genetic changes. Children deserve equal access to new treatments. The European Commission’s consultation, which is on-going, offers an opportunity to revise the rules in place and ensure clinical drug trials for children take place whenever new treatments come onto the market. Unless the loophole is closed quickly, there is a real possibility that childhood cancer treatments will not reach their potential for many years to come.
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