European directive "doubled" drug trial costs in UK

The European Union's clinical trials directive has stopped most clinical trials units in the UK from running studies in international centers, and three out of eight centers have been prevented from participating in a trial because of cost and compliance difficulties, according to a report in the European Journal of Cancer.

Coming after concerns over the impact of new regulations in the manufacture of chemical products (Marketletter December 7), the news will be seen as a blow to the competitiveness of the UK's drug research capacity.

"Rather than harmonizing and simplifying the regulatory environment, the Clinical Trials Directive has stopped most units from running trials in international centers," the study's authors said, noting that clinical study costs in the UK had doubled as a result of the regulatory burden. They also warned of "the very real danger that further malignant regulations will come out of Brussels."