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MEPs agree clinical trial regulation revision

Paves way for EU trial database and simplified online applications for new studies

EU flag Members of the European Parliament (MEPs) reached an agreement with member states on new rules for clinical trials, clearing the way for the regulation to come into force during this Parliamentary term.

The Committee of Permanent Representatives (COREPER) on Friday (December 20) endorsed the compromise text of the regulation, which covers a myriad of reform including the creation of a public, EU-wide database for all clinical trials of new medicines, a simplified trial application procedure via a single web portal and streamlined protocols for review and authorisation of studies.  

EU Health Commissioner Tonio Borg said the revised rules "will ensure that the EU remains an attractive location for clinical research, which is of vital importance for Europe's competitiveness and innovation capacity".  

The regulation also introduces a higher level of transparency in the clinical trials process, with lay language summaries available for all EU trials and access (on request) to clinical study reports (CSRs) for trials used to support a marketing authorisation application (MAA), with strengthened rules on patient protection and informed consent.  

The transparency drive was welcomed by UK MEP Glenis Willmott, the European Parliament rapporteur, who said: "For too long unflattering studies have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results.  

"It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective, or even dangerous."  

Industry trade organisation the European Federation of Pharmaceutical Industries and Associations (EFPIA) and its US counterpart made various commitments to boost clinical trial transparency in July, and was measured in its response to the regulation, saying the text "reflects [its] commitments towards responsible data sharing with researchers, patients and the general public".  

EFPIA did welcome many of the elements of the new regulation, which it said would help restore the EU's competitiveness as a location for clinical research. It is clear that something needs to be done, given that between 2007 and 2011, the number of clinical trials started in Europe fell by 25 per cent.  

The BioIndustry Association (BIA) added its own support for many of the new elements but reiterated concerns - voiced ahead of the COREPER meeting - that a compromise deal to extend the timelines for trial approval was a retrograde step.  

"Increasing the timeline to over 100 days for clinical trial approvals for advanced and innovative therapies is unlikely to boost clinical research in the EU," said BIA chief executive Steve Bates.  

The regulation is now forwarded to the Environment, Public Health and Food Safety (ENVI) committee for technical finalisation and approval, after which it will be voted on in the entire Parliament.

Article by
Phil Taylor

23rd December 2013

From: Research

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