EU Trial opt-out is affecting child cancer treatment

The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust have warned that the discovery of new drugs to treat childhood cancers is at risk because of EU legislation intended to encourage paediatric trials.

 

The rules in question permit drug companies to opt-out of testing their drugs on children where the IMP is intended to treat a cancer that doesn’t primarily affect children – such as lung cancer.

 

At first glance this seems an excellent idea - after all, the rules of good clinical practice insist that trials are only done under strict risk : benefit controlled conditions and that the well-being of the patient must always come first.

 

In 2007, the EU Paediatric Regulation was set up to try and improve children's access to new treatments.  

 

However, a drug developed for one cancer in adults, could still be extremely effective against another in children. In the past 5 years, opt-outs were granted for the drugs axitinib and obinutuzumab – both of which could potentially be effective against cancers that affect children.

 

Since 2012, 62% of approved EU cancer drugs were not even tested on under-18s.

 

Even ignoring the ethical issues – why should companies decide to ignore a revenue stream for their potential blockbuster drug?

 

Partly its economics – cancers are relatively rare in children so it would be harder for revenues to outweigh the high cost of the drug trials. Childhood cancers make up around half a percent of total cancers – at this rate it’d be hard to turn a profit.

 

This is the problem shared by conditions classed as “rare diseases” among all ages – so what is the solution?

 

Some form of economic incentive for companies carrying our paediatric trials in one way forward.  Another would be to reduce the lower age limit for “adult” trials to allow adolescents to be included where appropriate.

 

Something certainly needs to change!


Read more [here]

 


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