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International heart and sports medicine experts call for cardiovascular screening programme for athletes

January 30, 2005

Parents of children with rare diseases appealed this week to Europe's lawmakers to approve proposals for encouraging clinical trials involving children. The call came at a conference in Brussels organised by the European Forum for Good Clinical Practice (EFGCP). Throughout Europe, 15 million children suffer from rare diseases, said Yann Le Cam from the European Organisation for Rare Diseases, yet almost no new medicines are being produced with them in mind. "In drug development, children come last," he said.

Earlier, the conference had heard from European Commission official Peter Arlett about proposals - currently being considered by the European Parliament and the Council of Ministers - to encourage pharmaceutical companies to produce medicines specifically tested for babies and children.

"Children are not small adults," said Ysbrand Poortman, Chairman of the European Platform for Patients' Organisations and Industry. "Their bodies work differently. You can't just take an adult dose, reduce it in proportion to the child's size, and expect it do the same job."

Astonishingly, the conference heard, almost none of the medicines commonly used to treat babies and children have been subjected to rigorous clinical trials designed specifically for the young. "Concerns about conducting trials in children should be balanced by the ethical concerns about giving medicines to a population in which they have not been tested," said Arlett.

The EFGCP now aims to help Europe's parliamentarians when they come to approve the proposed regulations next spring. "Of course politicians are wary of putting the words 'children' and 'clinical trials' in the same sentence. But they have to understand that the parents of sick and dying children are desperate for solutions. Provided that these trials are carried out ethically and under tight controls, only when necessary and with minimum risk, the result will be a major contribution to child health," said Francis Crawley, Secretary General of the EFGCP

The outcome could also be a major contribution to Europe's economic health. The US is already nearly 10 years ahead of Europe with this kind of regulation, and any delay risks losing jobs and products across the Atlantic.

European Forum for Good Clinical Practice

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