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Europe to Revamp Clinical Trial Rules

After years of complaints, the European Commission proposes ways to fix its system in an effort to reinvigorate research on the continent.

Bob Grant
Bob Grant

Bob Grant is Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.

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Yesterday (July 17) the European Commission formally adopted proposals for new rules aimed at reviving medical research there by replacing an unpopular 2001 directive that researchers have derided for being too bureaucratic.

The reforms seek to cut much of the red tape involved with the Clinical Trials Directive by creating a central electronic portal for the submission of trial applications and regulating trials based on the levels of risk they entail, instead of applying the same rules to all trials.

In the last 10 years under the current directive, the number of clinical trials being conducted in Europe has plummeted, and insurance fees have skyrocketed, driving sponsors to other continents to complete studies. Commissioners hope that changing the directive will help ameliorate those problems. Markus Hartmann, a Germany-based regulatory affairs expert, told Nature that the proposed rule changes should help "in overcoming the most relevant shortcomings" in the current directive.

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