March 6, 2006

The EU clinical trials directive, established in 2004 to improve research standards and protect patients, is threatening clinical research procedures in Europe, according to a recent article published in the British Medical Journal. The article asserts that clinical investigators worry that the requirements of the new directive -- seen by many in the research sector as overly corporate and restrictive -- have negatively affected the clinical trial process though cost-cutting and decreased grant funding.

Since the directive's inception, according to the journal article, the number of new trials in Europe decreased by 63 percent between 2004 and 2005, and a third fewer patients were enrolled in studies. Concurrently, trial costs increased by 85 percent, while the amount of paperwork and documentation per trial also rose. This, in turn, suggests the article, ultimately hampers patient access to new treatments.

"Our own experiences are in accordance with these findings," write the journal's authors. They note that physicians, universities and research centers have been working to update the directives, with an increased focus on resource accessibility and more collaborative research efforts.