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.

By | July 18, 2012

image: Europe to Revamp Clinical Trial Rules

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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Avatar of: melitensis


Posts: 2

July 19, 2012

No less important than the bureaucracy is the out-dated regulation on testing requirements. Directive 2003/63/EC on the community code relating to medicinal products for human use makes the submission of animal data a legal requirement, whilst the submission of data obtained from human cell studies (e.g. pharmacogenomics) remains voluntary. This situation is well described in the recently published article by Greek et al.  


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