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Health of independent clinical trials in danger, scientist warns

European Union legislation due to take effect next year could have a disastrous effect on non-commercial clinical trials, said a leading cancer researcher today. Speaking at ECCO 12 - The European Cancer Conference in Copenhagen, Professor Franoise Meunier, Director General of the EORTC1 Brussels, Belgium, told a news briefing that the new rules, which will have to be implemented across Europe by May 2004, will cause great harm to academic clinical trials which are designed to help patients by improving public health.

The heart of the problem lies in the definition of a trial 'sponsor'. It is defined as one individual or organisation who will take total responsibility for the clinical trial. The pharmaceutical industry can cope with this, but the definition does not take into account the partnership structure that non-commercial trials often use. The extra financial cost to the sponsor of fulfilling all the regulations in the legislation will multiply cost by a factor of 3 to 4, researchers estimate, and the administrative burden will at least be doubled.

Critics of the directive say that it was drawn up by the commission's enterprise directorate, responsible for the pharmaceutical industry, and was designed with that industry in mind, thus ignoring the needs of academics running publicly funded clinical trials.

"It is highly unlikely that any organisation involved in publicly funded research will be able to take on the role of sponsor as described in the legislation," said Prof. Meunier. "Without a sponsor, trials to conduct independent evaluations and comparison of drugs will be forced to stop, and the only clinical studies in existence will be those run by the pharmaceutical industry."

"It is vital that national authorities are made aware of this and help us to preserve independent investigations by academic researchers and co-operative groups", she said. "We hope they will be able to introduce some flexibilit
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Contact: Mary Rice
mary.rice@blueprintpartners.be
45-3252-4163
Federation of European Cancer Societies
24-Sep-2003


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