Clinically challenged

When the EU introduced its draft clinical trial directive in 2001, academic institutions argued that the new procedures and requirements would add excessive paperwork and costs. The directive was put in place last May, and now companies are complaining as well. What's more, clinical research organizations inside and outside Europe warn that companies have started running more trials in the U.S. and elsewhere.

The Clinical Trial Directive 2001/20/EC was supposed to harmonize existing national regulations for clinical trials, including bioavailability and bioequivalence studies, but excluding non-interventional trials such as post-marketing studies. But the directive does not introduce a process akin to the mutual recognition procedure for drugs, so to run a multicenter trial across several EU member states, a sponsor still needs to submit a separate application in each state...