Better Late Than Never: The Road Map Initiative for Clinical Research in Europe A Chance to Get it Right
Brussels, 10 September, 2009 – As part of the Road Map Initiative for Clinical Research in Europe, academic and corporate stakeholders will gather for the second time in a series of 4 events aimed at presenting a unified recommendation (by April 2010) to the European Commission prior to their review of the Clinical Trials Directive. The main issue to be discussed is the current legislation regarding the sponsorship of clinical trials and its impact on clinical research.
The objective of Directive 2001/20/EC is to optimise patient safety, improve the efficiency of trials implementation , ensure best practice in ethical review and the regulatory process, and harmonize procedures across Europe. However significant concerns have been raised about the regulatory framework resulting from the implementation of the directive, notably with regards to trial sponsorship(individuals, companies, institutions or organisations taking legal responsibility for the initiation, management and/or financing of a clinical trial). Although it is widely agreed that the European Clinical Trials Directive has clarified the role of trial sponsors, it has also had a negative impact by establishing that there should be a single sponsor per trial, which entails that the unique sponsor has to take the entire responsibility for the management and financing of clinical trials, and that the sponsor has sole legal responsibility for the trial outcome. The associated financial and legal risks of trial sponsorship make it considerably difficult for academic institutions to take on the sponsorship of a trial. This unforeseen ‘knock-on’ effect and the negative impact that the Directive thus has on multinational academic investigator-led trials will be the focus of the workshop, which will seek to identify ideas and practical proposal for more research friendly Sponsorship conditions and improve collaboration.
Stakeholders representing every aspect of the trial process will discuss and attempt to achieve a common recommendation on how co-sponsorship could be implemented, and how contractual agreements between different sponsors should be defined in terms of roles and responsibilities. Examples of co-sponsorship will de discussed and analysed, notably the UK approach and the experience in Germany between National Lead Organisations.
The competitiveness of European academic research and the possibility to easily and effectively implement clinical trials at a multinational level are concerns that have already been discussed during the first workshop of the Road Map Initiative, held on July 7th in Brussels, where key actors of European clinical research discussed the likely recommendation to the European Commission to implement a single Clinical Trial Authorization for multinational clinical trials.
The outcome of this important series of workshops has the potential to change the way clinical research is conducted in Europe and re-ignite academic research which is being hindered by current public policy. The academic voice was lamentably quiet during the original elaboration of the Clinical Trials Directive. The Road Map Initiative for Clinical Trials Research in Europe intends to make sure that this is not the case when the European Commission begins its review of the directive in 2010. The initiative also aims to add strength to that voice by bringing together all the key stakeholders and presenting common recommendations for the way forward.