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Royal Liverpool to lead paediatric medicines initiative
Friday , March 18, 2005

The Royal Liverpool Children's NHS Trust and the University of Liverpool are to lead a £20 million initiative to research and develop new medicines for children, with involvement from the pharmaceutical industry and healthcare professionals central to the plans.

The UK Medicines for Children Research Network will develop a wide variety of new paediatric drugs, including those for prevention and treatment of diseases affecting newborns and children on intensive care.

The initiative is needed because of a severe shortage of medicines developed specifically for children. The issue of paediatric clinical trials is one of the most difficult for the industry in terms of ethical, medical and regulatory problems, and currently acts as a deterrent to industry investment.

The ABPI estimates that over 90% of medicines used in newborns and 45% used in general paediatric care have never been tested or licensed for use in children. Doctors have little choice but to use them off-label, but this raises serious questions over safety and efficacy.

Dr Richard Tiner, ABPI director of medicine commented recently: "This situation needs to be changed but clinical trials in so many age groups are expensive, the market for companies is small and persuading parents to allow their children to participate is understandably difficult."

Meningitis, asthma, epilepsy and migraine are some of the priority areas for the development of new medicines through the network, which is part of the wider Clinical Research Collaboration (CRC) promoting new multi-stakeholder research alliances in the UK.

Rosalind Smyth, professor of paediatric medicine at the University of Liverpool and based at the Royal Liverpool (also known as Alder Hey) Children's Hospital will become director of the new co-ordinating centre.

"This national initiative has the potential to make a real difference for children, parents and prescribers by making sure that existing and new medicines are tailored to the needs of children."

She concluded: "Children have the right to the same standards of medicine as adults and this strategy is another step towards achieving this."

The initiative has been developed in collaboration with Imperial College, London, Liverpool Women's Hospital, the National Perinatal Epidemiology Unit at the University of Oxford and the National Children's Bureau.

The £20 million government grant will cover a five-year period with the aim of establishing a world-class health service infrastructure to support clinical research and promote good clinical practice and quality in clinical trials.

The ABPI launched its own guide for the industry on paediatric trials earlier this year, and included contributions from the NHS, MHRA and patient group Wellchild.

A vital component of the new initiative is the creation of a national IT system for research data capture, storage and retrieval, based in Liverpool.

The Co-ordinating Centre will establish local research networks across the UK to support clinical research, particularly in primary care.

 

 


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