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It’s time for change to EU regulations on children’s cancer trials

Posted on 10 February, 2014 by Eva Sharpe
46b4043550840191a108f74c2077Today The Institute of Cancer Research, London, is calling for a change in the way that EU policy on children’s cancer is implemented, on the grounds that the current system is denying children access to the latest cancer drugs.

For the last few months I’ve been working with our paediatric researchers and others across the ICR on a project looking at how we can increase access to clinical trials for children with cancer.

Today the project went public, as our Chief Executive, Professor Alan Ashworth, and one of our leading paediatric researchers, Dr Louis Chesler, told a press briefing that EU regulations on trialling new drugs in children needed to be revised to ensure cancer drugs developed for adults are also tested in children whenever they could be effective.

Here at the ICR we are pioneering the discovery and evaluation of new targeted therapies specifically designed to combat childhood cancer.

We aim to understand how childhood cancers develop, to design new ways of directly targeting the genes implicated in children’s cancers, and to work with our colleagues at The Royal Marsden on trials to move these drugs into the clinic. These specific, targeted therapies should be more effective and with far fewer side-effects than conventional chemotherapy, and the aim of course is to cure children who are currently dying of cancer.

We're currently trying to raise £60,000 to support even more of this work, for example in childhood brain cancers where there is a desperate need for new-style targeted therapies. But funding isn't the only thing holding this vital research back.

The EU Paediatric Regulation, which came into force in 2007, has up to a point been a step forward in getting more of these new style drugs into early-stage paediatric clinical trials – but loopholes in the regulation are now causing serious problems.

Under the legislation, if a drug may be suitable for children, pharmaceutical companies are obliged to develop a paediatric investigation plan (PIP), describing how the drug will be studied for potential paediatric use, before they can gain marketing authorisation for the drug in adults.

A company can get a waiver from developing a PIP and trialling the drug in childhood cancers if the product is unlikely to be effective or safe in children, if it does not represent a significant advance over existing treatments, or if the disease the drug is intended for does not occur in children, like lung cancers.

It is this system of waivers that the ICR is calling to change. In practice, many adult cancers do not have direct equivalents in children, but that doesn’t mean that adult cancer drugs can’t be effective in children’s cancers.

Modern cancer drugs are often designed against specific molecular mechanisms, rather than for a particular cancer type, and these mechanisms may well be common to both adults’ and children’s cancers.

As a result, there are instances where potentially important cancer drugs are given a waiver from testing in children, even though the drugs could be effective against other types of children’s cancer.

Revising the waiver system for paediatric medicine could bring new types of drugs to the clinic for children and make a huge difference to survival rates in childhood cancers.

The European Commission recently consulted on the way that the PIP system works and will be considering whether any changes are needed over the next few months.

The ICR of course fed in our views. We’re really hoping the EC revises the system to help bring innovative new cancer treatments to children who need them. I’ll be watching out for its decisions and will let you know the results.

Image: Wellcome Images, Creative Commons by-nc-sa


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