Concerns raised over impact of clinical trials directive

November 4, 2005

Brussels, 03 Nov 2005

Concerns have been expressed at the 13th European Cancer Conference in Paris that the recently introduced EU clinical trials Directive is having a restrictive effect on the number of new cancer trials being carried out in Europe.

The aims of the Directive - to harmonise legal provisions for the establishment, conduct and reporting of clinical trials, implement good clinical practice and ensure patient safety - are noble, according to a statement by the Federation of European Cancer Societies (FECS).

'Yet there are concerns that its mandatory implementation will be to the detriment of future non-commercial trials as requirements, obligations and clinical costs associated with the new legislation continue to increase,' the statement continues.

To investigate the impact of the Directive, a comparative analysis was undertaken in eight different Member States to assess the differences, obstacles and pitfalls in the conduct of future investigator-led multi-centre trials in Europe. The analysis reveals that only a few Member States have added provisions for non-commercial trials when transposing the legislation, and that no common definitions exist across the EU for the terms 'investigator-initiated' and 'non-interventional studies'.

'The conclusion is that the new legal framework for clinical trials renders the realisation of future pan-European multi-centre studies much more difficult. There has been a failure to simplify the conduct of academic clinical trials in the European trial space,' reads the FECS statement.

According to Dr Markus Hartmann from European Consulting & Contracting in Oncology in Germany, who co-authored the study: 'Overall it appears that just one year after its implementation, the clinical trials directive has resulted in a harsh drop-down in the number of new investigator-initiated clinical trials and instead is promoting primarily the conduct of nationwide projects. In paediatric oncology and cancers of very low incidence, the expected drop-down of available clinical trials will constitute a major challenge for all stakeholders, including patients and physicians as well as drug manufacturers and policy makers.'

In contrast, however, new European pharmaceutical legislation due to come into force on 20 November received a much more positive review at the ECCO conference. The legislation will require all cancer-related drugs seeking EU approval to be evaluated by the European Medicines Agency (EMEA), and includes new provisions allowing for early access to drugs, including anticancer drugs. 'The new EU approval legislation scheduled for implementation in November [looks to be a positive] step which might hasten patient access to important new cancer medicines,' concluded Dr Hartmann.

Further information

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