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 more difficult. There has been a failure to simplify the conduct of academic clinical trials in the European trial space. In addition, radiotherapy studies, trials investigating surgical techniques and some multimodal trial concepts remain out of the scope of the revised legislative texts in some cases. In certain member states, non-interventional trials allow limited research in the form of observational studies outside of the new legal framework although these are heavily restricted to small Phase I/II case series within or in close proximity to the approved prescription window given by drug labeling.

In contrast, the new European pharmaceutical legislation due to come into force on the 20 November 2005 received a more positive introduction and review at ECCO 13. Regulation (EC) No 726/2004 will entail that all oncology drugs seeking approval in the EU will be evaluated via the European Medicines Agency (EMEA) leading to an EU-wide approval.

The legislation will contain new tools and procedures allowing early access to new drugs, including anticancer drugs. One of these measures is the 150 days accelerated procedure (instead of 210 days) for drugs that are of major public health interest, particularly in terms of therapeutic innovation. Moreover, renewable conditional authorisations may be granted for certain products pending completion of further studies. Importantly, the new rules will retain the existing mechanism of approval under exceptional circumstances when the rarity of the indication, the state of the scientific knowledge or the principles of medical ethic do not allow for the provision of comprehensive data on the efficacy and safety of such products. In addition, the EMEA may permit cohort compassionate use of certain products.

"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 research projects," noted Dr Markus Hartmann from the European Consulting & Contracting in Oncology, Germany. "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. On the other side of the coin, the new EU approval legislation scheduled for implementation in November, as well as the new GCP Directive which must be transposed until January 2006 into member state legislation, look set to be positive steps which might hasten patient access to important new cancer medicines. Anyway, both Directives promote trial participants' safety undoubtedly by setting uniform and unmistakable standards of patient protection across Europe, judged necessary especially in case of experimental therapy forms like innovative biological medicinal products or therapies with engineered cells."

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Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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