EBMT

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Clinical Trials - EMEA Meeting Update

 

Prospective Clinical Trials Update EMEA Meeting on the Operation of the Clinical Trials Directive

 

Meeting on the Operation of the Clinical Trials Directive

 

The EU Commission and EMEA (European Medicines Agency) jointly held a conference on the 3rd October in London with the aim of offering an opportunity for all stakeholders to discuss the impact of the EU Directives on Clinical Trials. Held at EMEA Headquarters, both the speakers and delegates represented the legislators, the pharmaceutical industry and academic research as well as those from groups representing patients. Professor Dietger Niederwieser was the EBMT delegate and Zoë Doran, Director of Clinical Trials Operations attended as an observer.

 

Thomas Lönngren, Executive Director EMEA, opened the meeting stating that experience had shown problems with the EU Directive and that there were clearly operational difficulties conducting research within the framework of current legislation. The conference would review the EU Directives and their implementation to date and look for solutions and recommendations for the future.

 

Overall the meeting was very positive, the atmosphere collegial and there seemed to be a genuine interest from the Commission in addressing the problems that are strangling academic research. This was most clearly demonstrated by the news that there was already a task force in place with the remit of addressing the impossible Pharmacovigilance reporting requirements.  It was also supported by the delay in the publication of the new guidelines for non-commercial trials, drafted last year.  

 

Academia and Industry obviously concurred although there was some doubt about the legislators after Professor Hartmut Krafft’s, (Chair of the Clinical Trials Facilitation Group) presentation, during which he gave his opinion that there were no real difficulties that could not be resolved by clarifications and guidelines! His view was strongly rejected by virtually every other presentation, and the consensus was that there are indeed major problems, some of which could be improved by modifications in current legislation but further legislation would be needed.

 

The presentations were somewhat repetitive as each group reported the same difficulties but that at least served to re-enforce the message that change was mandatory. Some of the main points were:

 

The meeting was focused more towards identifying the problems rather than suggesting solutions. It would have been useful to have had a workshop type forum in the second half of the day to come up with some solutions. For example, although it was widely considered that there should be clear and sensible definitions for Investigational Medicinal Product (IMP) and Non-Commercial Trials but no suggestions were made. At the end of the conference the EMEA invited participants to write to them with any further comments of questions that the participants felt had not been made. The EBMT’s response will include suggestions for definitions of both IMP and Non-Commercial Trials as well as the suggestion that there should be a further meeting focused on solutions.

So what is the way forward?  A report will be published detailing the discussions of this conference, which will include any further documentation received from the participants. It is hoped that this is the first of multi-disciplinary meetings and that future meetings will produce solutions to the problems either by clarifications/modifications of current legislation and additional Directives

 

 

Zoë Doran
Director Clinical Trials Operations

 

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