Lack of harmony in European clinical trial regulations is hurting patients

November 20, 2002

Frankfurt, Germany: International clinical trials within Europe are being hamstrung by red tape and disparate legal regulations in different countries, the Director-General of one of Europe's leading cancer research organisations told a Frankfurt news briefing today (Wednesday 20 November).

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, Professor Françoise Meunier told the briefing at the EORTC-NCI-AACR[1] Symposium on Molecular Targets and Cancer Therapeutics.

"It leads to pitfalls without improving patients' safety or the quality of science and cancer care," she said.

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 and applied by May 2004 - was a step towards promoting the conduct 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 were too many key topics in the Directive open to too broad an interpretation by national authorities. These included 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.

Professor Meunier highlighted the example of tissue and biological sample research, which had emerged as a rapidly growing area to facilitate the passage of experimental discoveries into state of the art treatments for cancer patients. This usually involved networks of academic laboratories and clinical investigators. Clinical trials encountered problems related to tissue research that could impact on informed consent procedures.

"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.

Intergroup studies - large clinical trials conducted by several networks of investigators with a single co-ordinating data centre, a single protocol and one set of case report forms - also faced drawbacks. Professor Meunier said that the EORTC was currently struggling with a series of new logistic, legal and methodological problems encountered during collaborations.

Insurance was 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.

"Non-pharmaceutical research plays a vital role. It is often best positioned to detect medically relevant difference in diagnostic and therapeutic interventions that could translate into major public health advances. There is a real risk that European public health policy makers and national authorities may marginalise key areas of biomedical and health research by developing policies without fully taking into account the scientific environment and economic structure of independent research.

"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," Professor Meunier concluded.

[1] EORTC [European Organisation for Research and Treatment of Cancer; NCI [National Cancer Institute]; AACR [American Association for Cancer Research].

Further information:
Margaret Willson (media information officer)
Tel: 44-153-677-2181
Fax: 44-153-677-2191
Mobile: 44-797-385-3347

From: 16:00hrs CET Monday 18 November to 17:00hrs CET Friday 22 November:
EORTC-NCI-AACR symposium press office:
Tel: 49-697-5757-3294
Fax: 49-697-5757-3451

European Organisation for Research and Treatment of Cancer

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