Lack of harmony in European clinical trial regulations hurting patients

Brussels, 21 Nov 2002

EU countries must harmonise their rules on clinical trials, the Director-General of the European Organisation for Research and Treatment of Cancer (EORTC), Professor Francoise Meunier, has warned.

Professor Meunier told the Symposium on molecular targets and cancer therapeutics in Frankfurt, Germany on 20 November, that 'international clinical trials within Europe are being hamstrung by red tape and disparate legal regulations in different countries.'

According the Professor Meunier, a 'lack of harmonisation in national legal obligations is jeopardising progress in establishing state of the art treatment strategies, denying patients the benefits of advances and hampering Europe's ability to compete with countries outside Europe. It leads to pitfalls without improving patients' safety or the quality of science and cancer care.'

Professor Meunier was voicing concerns felt by European oncologists and research scientists despite the adoption in 2001 of the EU Directive on good clinical practice.

Although the directive, due to be implemented in European Member states' law in May 2003, was a step towards promoting the use of clinical trials and facilitating clinical research, there was a risk that it would fail to establish the appropriate legal and regulatory framework to avoid duplication of research and cut the time needed to establish state of the art treatments. Professor Meunier warned 'to succeed, its implementation into national laws must take pan-European research into account and also independent academic trials not aiming at drug registration.'

Professor Meunier said that there are too many key topics in the directive open to too broad an interpretation by national authorities. These include ethical approval and protocol amendment procedures, regulations for reporting serious adverse events, informed consent documentation, requirements for drug labelling, costs of non-sponsored trials, translational research issues such as exchange of tumour materials and tissue research and insurance requirements by ethics committees.

'It would be extremely detrimental if the implementation of the directive within national legislation is not taking into account the network of investigators conducting strategies trials with registered drugs. At a time when the European Commission and the European Parliament wish to boost cancer research, to maintain existing expertise in Europe and to promote our international visibility, any serious drawbacks and threats to the competitiveness of European research should be avoided at all costs,' she said.

Obstacles to pan-European clinical research also applied to other specialities such as emergency medicine and cardiology, but cancer research was especially vulnerable being a particularly complex field requiring multi-disciplinary and multi-modality treatment.

'We see too many drifts in documents drawn up by non-medically qualified people who tend to adapt sometimes conflicting directives and national requirements. Patients should be offered the chance to join a clinical trial with comprehensive yet pragmatic and understandable information. Countries need to have clear rules and regulations in common if research is not to be seriously hampered by bureaucracy and misinformation,' said Professor Meunier.

Insurance is another minefield, with differences between countries having a tremendous impact on insurance premiums without sound scientific justifications and without improving quality of research and care.

'Despite the original goal of the directive to facilitate clinical research in Europe, the regulatory hurdles and approval process may persist. It remains to be seen whether the directive will actually decrease the high level of complexity faced by investigators and promoters of research,' she said.

Professor Meunier concluded by saying that 'the creation and strengthening of networks of excellence within the European Research Area will be seriously jeopardised unless there are appropriate strategies to initiate and effectively conduct pan-European clinical trials and tissue research under an optimal legal framework that can collaborate with countries such as the USA, Australia and Japan as equal partners.'

CORDIS RTD-NEWS/© European Communities, 2001