Because many drugs have not been properly tested on the young, health professionals have to fall back on their skill and judgement when prescribing medicines for children. Now the UK will conduct trials of registered drugs to inform these decisions.
The Medicines for Children Research Network is part of a government plan to make the UK a leading destination for carrying out clinical trials. A number of other national clinical trials networks have been established in other fields such as cancer, cardiovascular disease and central nervous system diseases.
The network involves health professionals, the pharmaceutical industry and children and parents. A Young Person’s Advisory Group has been established which comprises 17 young people aged from nine to 18, who will work with project leaders on publicity material for children about the initiative, and will act as ambassadors to encourage young people receiving medical care to participate in research projects.
Added incentive
In June drug companies were given an incentive to carry out safety testing in children when EU legislation was approved granting a six-month patent extension in the case of standard treatments, and a two-year extension to the patent life of orphan drugs – if they carried out safety and dosage trials on children.
In addition, there is a new designation, the Paediatric Use Marketing Authorisation, which will provide 10 years’ patent protection for companies that carry out paediatric clinical trials of off-patent drugs.
Currently, more than 50 per cent of medicines have not been tested in clinical trials in children, and subsequently are not licensed for paediatric use. This is due both to concerns about the ethics and safety of conducting trials in children and because they represent a small market.
The Directive included plans to improve the robustness of pharmacovigilance for medicines in children, and the setting up of an EU-wide network of investigators and trial centres with the capability to conduct paediatric trials.
Drug companies have to submit a paediatric investigation plan when they file for drug approvals for adults. There are waivers for drugs that are unlikely to benefit children and a system for allowing paediatric testing to be deferred if this would delay authorisation of treatments for adults.
Rosalind Smyth, professor of paediatric medicine and director of the UK coordinating centre, said setting up the UK network was the most important development towards improving children’s health that has happened in her professional career. “We now have – in partnership with the pharmaceutical industry and other organisations that fund medical research – a real opportunity to provide medicines which will be of specific benefit to children.”
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