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Review of the European Clinical Trials Directive: Patients’ Rapid Access to Treatment and European Research Competitiveness at Stake
Brussels, 27 July 2009 – European academic researchers, representatives from pharmaceutical industry, clinical research organisations, ethics committees, European Commission, and patient organisations gathered in Brussels to discuss options for a review of the Clinical Trials Directive (DIR 2001/20/EC) in 2010, with the objective to understand the different stakeholders’ viewpoints and to work towards agreement on united recommendations for new legislation. During this first of five workshops of the Roadmap Initiative for Clinical Research in Europe, stakeholders discussed how patients and European research are affected by the Clinical Trials Directive and the possibility of implementing a Single Clinical Trial Authorisation (CTA) in Multinational Clinical Trials.
Although commercial sponsors pointed out that the Directive has brought some improvements, notably by incorporating the principles of Good Clinical Practice and Good Manufacturing Practice, attendees agreed that the directive has hampered pan-European harmonisation and made the procedure more costly and time consuming. Indeed, the content of the CTA application is currently defined by each member state and later reviewed by each national ethics committee who request amending the protocol according to national ethical requirements. Multinational clinical trials are consequently made more difficult as the application has to go through a number of competent authorities before approval. Jacques Demotes, from the French National Institute for Health and Medical Research (INSERM), questioned whether “clinical trials for a single medicinal product really need up to 27 different evaluations in different countries?”. “Obviously not” he said.
The issue is significant in particular for academic trials which are often cross-border partnerships between different universities. Besides, academics typically do not have the resources to support the necessary bureaucratic workload. Alan Tyndall from the University of Basel, Switzerland raised the issue of European research competitiveness and attractiveness if it takes longer for clinical trials to get started and if Investigator Initiated Trials (IIT) research focuses are limited by a lack of funding. Dietger Niederwieser from the University of Leipzig, Germany, and president of the European Group for Blood Marrow Transplantation (EBMT) illustrated this point by observing that tremendous progress in Stem Cell Transplantation [the only curative treatment for many haematological malignant diseases] is due to research conducted during the last 50 years, with trials which would be impossible under the current legislation.
Discussions also largely focused on the well-being of patients, who are at the heart of the debate. Ruth Ladenstein from the St Anna Children’s Hospital in Vienna, Austria, pointed out that paediatric trials suffer from not adapting trials requirements to risks and from insurance requirements. “The success story in paediatric cancer over the past two or three decades is due to academic trials”, she said, adding, “it is precisely these trials that are in danger because of the bureaucratic load introduced by the current Directive.” She underlined that “one trial on neuroblastoma is going ahead only because it has funding from patients”. “We need more support from the European Union” she said.
Several suggestions for improvement came out of the workshop including:
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a single CTA for multi-national trials
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the implementation of a single Clinical Trial Application dossier in English;
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the amendment of the directive to allow co-sponsorship;
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a regulatory oversight proportionate to the risk of the clinical trial;
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a single ethical opinion for Europe with national input
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single application of SUSARs into a central database;
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agreement on the definition of an investigational medicinal product, substantial amendment, noninterventional trial.
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financial support for infrastructure and insurance requirements for academic trials
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Governmental support for insurance requirements to cover trial protocols
The next workshop is due to take place in London on 21 September 2009. It is entitled ‘Innovative Approaches to Clinical Trials Co-Sponsorship in the EU’ and aims to explore the challenges of single sponsorship under the EU Clinical Trials Directive.
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