The Scientist

3 March 2004

Crunch-time for EU directive

Researchers still worried that implementing clinical trial law will harm academic research | By Stephen Pincock

Even before Europe's new clinical trials directive (2001/20/EC) was signed into EU law, some research bodies were warning that it would have a devastating impact on academic clinical trials. Now, with just 2 months to go until the law is supposed to be enacted by member countries on May 1, groups like the European Organization for Research and Treatment of Cancer (EORTC) are still lobbying hard in the hope that something can be done to avoid what they see as a disaster in the making.

The aim of the directive is to make the regulation of clinical trials across the European Union uniform while protecting participants. The problems, as some researchers see them, lie in increased legal and financial burdens that the law imposes on the organizers of a trial.

These include strict reporting and monitoring rules, drug manufacturing for marketed drugs, fees to ethics committees and authorities, and increased administrative work. Variations in applying the directive from country to country could also swamp international studies in paperwork, researchers warn.

All this may be borne by a drug company, researchers say, but is financially impossible and in some cases unnecessary for