New European legislation impacts on both cancer trials and drug approval

New European legislation impacts on both cancer trials and drug approvalParis, France, Wednesday 2 November 2005 - New European legislation looks set to expedite patient access to important oncology products, according to discussions at the 13th European Cancer Conference (ECCO). Yet concerns were also voiced that the recently implemented Clinical Trials Directive is having a converse effect, restricting the number of new cancer trials carried out by impinging on the conduct of international, investigator-initiated, multicentre studies within Europe.

The aims of the Clinical Trials Directive are noble to harmonise legal acts for the set-up, conduct and reporting of clinical trials, implement GCP-principles Europe-wide and enforce patient safety. 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. In order to investigate differences, obstacles and pitfalls for the conduct of future multicentre trials in member states, a comparative European analysis was undertaken.

Evidence from this examination of 8 member states whose legislation has been adapted in line with the new requirements highlights major differences in the scope of the revised legislations, as well as differences in sponsorship and liability issues. The findings described at ECCO reveal that only a few member states have expressively added provisions for non-commercial trials into their legislation for example, by specifying the use of commercially available products or allowing for exemption from IRB/dossier approval fees. Furthermore, no common definitions exist throughout the EU for 'Phase IV' studies, nor the term 'investigator-initiated' or '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 mo

Contact: Kirsten Mason
Federation of European Cancer Societies

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