;   Medical Translation Insight: Frustrated by Clinical Trials Directive? Help is on the way - ForeignExchange Translations

Frustrated by Clinical Trials Directive? (medical translation)In 2004, the European Union issued a clinical-trials directive to harmonize clinical trials research across its 25 member countries and better protect trial participants. Rather than fixing the problem, though, the directive made things worse. (Take a look at this article [PDF link] in the Journal of the National Cancer Institute for a good discussion of the issues.)

Help has been long hoped for and worked on but change is finally coming. CMAJ reports that

"the European Commission is proposing to substantially overhaul the clinical trials environment on the continent so that it features a more streamlined, centralized and harmonized application procedure; a more 'risk-based' approach to regulation that reduces industry's reporting and insurance requirements; and reduced costs for both pharmaceutical firms, who sponsor 60% of trials on the continent, and academics and other organizations, who pick up the tab for the remaining 40%."
The proposed update aims for nothing short of restoring Europe's reputation as an attractive place for clinical trials. This may be a tall order given the almost 25% decline over the past five years in the number of applications to conduct clinical trials in the European Union.

Head on over to the CMAJ article for all the details. The Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [PDF link] is expected to take effect in 2016.

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