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 flexibility into the European legislation to allow us to continue to help patients with cancer and other serious diseases." Children's cancers and rare adult cancers are likely to be particularly hard hit, she warned. "Very few children get cancer and therefore it is not of commercial interest to the pharmaceutical industry. It is through academic research and trials that we have come to see such big improvements in mortality from childhood cancers - the rates have fallen in the past 25 years from nearly 100% to 25%. The Directive puts the future of research into childhood cancers seriously under threat', said Prof. Meunier.
Surgery and radiotherapy are also important in curing cancer, he said, and both techniques can benefit from the further improvement that is only possible through publicly funded clinical trials.
1European Organisation for Research and Treatment of Cancer