Children 'being excluded from cancer drug trials'
9th March 2017 – Children with cancer are missing out on potentially lifesaving treatments because of outdated European regulations, according to cancer experts.
They say these rules allow pharmaceutical firms to opt-out of running clinical trials of drugs in children, even when there is good evidence that they could benefit from taking part.
Who has issued this warning?
The warning is being made by The Institute of Cancer Research (ICR) in London and The Royal Marsden NHS Foundation Trust.
They have set out their concerns as the European Commission consults on the future of clinical trials in the EU involving children.
What concerns do they have?
Essentially, the cancer experts say nowhere near enough cancer medicines are being trialled in children or licenced for their use.
EU regulations were changed in 2007 in an effort to improve children's access to new treatments. But they say a flaw in the regulations was to allow drugs companies to apply for an opt-out from having to include children in clinical trials if it targets a cancer that does not affect children, such as lung cancer.
They can still apply to the European Medicines Agency (EMA) for this waiver even if the drug could potentially be used to treat cancers in children.
Have there been examples of such drugs?
In the past 5 years, opt-outs have been granted for the drugs axitinib and obinutuzumab.
Cancer experts say both drugs might be effective against a range of cancers in children.
An analysis of European data by the ICR found that between 2012 and 2016, pharmaceutical companies were granted waivers from having to trial cancer drugs in children for 33 of 53 cancer treatments which were ultimately licenced for use.
Why might drug companies seek opt-outs?
Creating new drugs is an extremely expensive business.
Drug companies may prefer not to have to invest money in developing cancer treatments for children, for whom cancers are rare compared with adults.
Childhood cancers account for only 0.5% of all cancers in the UK with around 1,600 cases being diagnosed each year among children aged 0 to 14.
What is the ICR and The Royal Marsden calling for?
Both organisations say the current consultation is the perfect opportunity to change the rules to ensure more children are involved in cancer drug trials. They're concerned that if this doesn't happen, another opportunity may not occur for years.
Among the recommendations, the ICR and The Royal Marsden want a lower age limit for adult trials so researchers can include adolescents where clinically appropriate.
They also want to see stronger economic incentives to compensate drug companies for the extra cost of developing treatments for children.